A composition containing 5-methoxy-N,N-dimethyltryptamine (5-MEO-DMT) for use in the treatment of mental disorders.

Abstract

To provide compositions for use in treating major depressive disorder.SOLUTION: Provided is 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in treating a patient who is diagnosed with major depressive disorder by a licensed professional in accordance with accepted medical practice, where the 5-MeO-DMT is administered via the intravenous, intramuscular or subcutaneous route.SELECTED DRAWING: None

Description

Technical Field

[0001] The present invention is directed to an improved method for the treatment of psychiatric disorders, particularly major depressive disorder , comprising administering a therapeutically effective amount of 5-methoxy-N,N-dimethyltryp , persistent depressive disorder, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse, to a patient in need thereof.

Background Art

[0002] Hallucinogens are chemical substances that are partly naturally occurring and partly synthetic, and are capable of inducing sensory distortions in humans after ingestion, such as auditory and visual changes, as well as mood and cognitive distortions, and are defined by their ability to do so. The term hallucinogen encompasses a fairly broad group of psychoactive molecules with different modes of action. Some psychiatric disorders have been suggested to be responsive to treatment with psychoactive molecules in principle.

Summary of Invention

[0003] The present invention relates to 5-methoxy-N,N-dimethyltryp tamine (5-MeO-DMT) for use in the treatment of psychiatric disorders, particularly major depressive disorder , persistent depressive disorder, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse, comprising administering a therapeutically effective amount of 5-methoxy-N,N-dime thyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, to a patient in need thereof.

[0004] The present invention particularly relates to 5-methoxy-N,N-dimethyltrypt amine (5-MeO-DMT) for use in the treatment of a patient diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice​ This relates to tamin (5-MeO-DMT) or its pharmaceutically acceptable salts. This disorder is caused by, According to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association A diagnosis may be made. For example, the patient may have 20 or more Montgomery-Asberg depression rating scales. (MADRS) score, or Hamilton Depression Rating Scale (HAM-D) score of 17 or higher. They may have moderate or severe major depressive disorder as indicated by the score. Those with a Montgomery-Asberg Depression Rating Scale (MADRS) score of 35 or higher, Or severe depression as indicated by a Hamilton Depression Rating Scale (HAM-D) score of 25 or higher. The patient may be diagnosed with major depressive disorder. It may be refused.

[0005] Furthermore, patients may experience suicidal ideation, particularly suicidal ideation accompanied by an intention to carry it out. In some cases, they may even be at imminent risk of suicide.

[0006] In the context of the present invention, 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered intravenously. It is administered intramuscularly or subcutaneously.

[0007] 5-MeO-DMT or its pharmaceutically acceptable salts are used to induce supreme psychedelic states in patients. It may be administered in a dose or dosage regimen that allows for an experience. Approximately 1 mg to approximately 10 mg A dose of 5-MeO-DMT or an equimolar amount of a pharmaceutically acceptable salt may be administered. .

[0008] 5-MeO-DMT or a pharmaceutically acceptable salt is administered in the first dose. It may be administered in 0 to 6 subsequent doses, each subsequent dose being given when the patient is at their best. A dosage higher than the previous administration is used unless a psychedelic experience is undergone.

[0009] The interval between two administrations may be 1 hour or more and 24 hours or less, preferably about 2 to 4 hours.

[0010] The occurrence of a peak psychedelic experience can be identified by achieving at least 60% of the maximum possible score on each of the 30-item Revised Mystical Experience Questionnaire (MEQ30) of the four subscales (mystical, positive mood, transcendence of time and space, and ineffability), and can be identified by achieving at least 60% of the maximum possible score on the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) Questionnaire, or identified by achieving at least 60% of the maximum possible score on the Oceanic Boundlessness (OBN) dimension of the Altered States of Consciousness (ASC) Questionnaire, or preferably identified by achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). identified by achieving 60%, or preferably identified by achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ).

[0011] The treatment set forth above with 5-MeO-DMT or a pharmaceutically acceptable salt thereof produces a clinical response. This response may be determined by a score of at least "much improved" on the Clinical Global Impressions - Improvement (CGI-I) scale or the Patient Global Impression of Improvement (PGI-I) scale, and the improvement preferably occurs within about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. occurs within about 2 hours after the last administration of the pharmaceutically acceptable salt thereof.

[0012] The clinical response, as determined by a score of at least "much improved" on the CGI-I scale or the PGI-I scale, is preferably maintained for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable The clinical response, as determined by a score of at least "much improved" on the CGI-I scale or the PGI-I scale, is preferably maintained for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably at least 14 days, particularly at least 28 days after the last administration. lasts until at least 28 days later.

[0013] The clinical response may also be determined by at least a 50% improvement in the MAD RS or HAM-D score, as compared to the respective baseline score prior to administration of 5-MeO-DMT. This response preferably occurs within about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Furthermore, remission of depressive symptoms, as determined by a MADRS score of 10 or less or a HAM- D score of 7 or less, preferably occurs within about 2 hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[0014] The clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score as compared to the respective pre-treatment score, preferably persists for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably for at least 14 days, particularly for at least 28 days. The clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score as compared to the respective pre-treatment score, preferably persists for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably for at least 14 days, particularly for at least 28 days. The clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score as compared to the respective pre-treatment score, preferably persists for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably for at least 14 days, particularly for at least 28 days. The clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score as compared to the respective pre-treatment score, preferably persists for at least 6 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably for at least 14 days, particularly for at least 28 days.

[0015] Preferably, the clinical response, as determined by at least a 75% improvement in the MADRS or HAM-D sco re as compared to the respective pre-treatment score, is present on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, more preferably also on day 14, particularly also on day 28. Even more preferably, the patient is, on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, preferably also on day 14, particularly also on day 28, in a state of remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. a pharmaceutically acceptable salt thereof, preferably also on day 14, particularly also on day 28, in a state of remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 8, in a state of remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. in a state of remission of depressive symptoms.

[0016] Examples of the present invention include the following: [1] 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof for use in the treatment of a patient diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice, wherein the 5-MeO-DMT is administered by an intravenous, intramuscular or subcutaneous route. [2] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] above, as the disorder is diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association. [3] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] or [2] above, for patients suffering from moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more, or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. [4] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [3] above, in which the patient suffers from severe major depressive disorder as indicated by a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. [5] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [4] above, for the patient diagnosed with treatment-resistant major depressive disorder. [6] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [5] above, if the patient also suffers from suicidal ideation. [7] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [6] above, for patients suffering from suicidal ideation accompanied by an intention to carry it out. [8] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [7] above, in cases where the patient is at imminent risk of suicide. [9] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [8] above, administered in a dose or dosage regimen that causes the patient to experience a supreme psychedelic experience.

[10] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [9] above, wherein a dose of 5-MeO-DMT is administered in amounts of approximately 1 mg to approximately 10 mg, or equimolar amounts of a pharmaceutically acceptable salt thereof are administered in place of 5-MeO-DMT.

[11] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to [9] above, administered in doses of approximately 2 mg, 5 mg, or 8 mg, or administered in equimolar amounts of a pharmaceutically acceptable salt instead of 5-MeO-DMT.

[12] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[10] above, wherein 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered in a first dose in a first dose, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, each subsequent dose being higher than the previous dose unless the patient experiences a supreme psychedelic experience.

[13] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[12] above, wherein 5-MeO-DMT is administered in a first dose of approximately 1 mg to approximately 3 mg, then increased to a second dose of approximately 4 mg to approximately 6 mg unless the patient has already experienced a supreme psychedelic experience, then increased to a third dose of approximately 7 mg to approximately 9 mg unless the patient has already experienced a supreme psychedelic experience, or an equimolar amount of a pharmaceutically acceptable salt thereof is administered instead of 5-MeO-DMT.

[14] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[13] above, wherein the first dose of 5-MeO-DMT is approximately 2 mg, the second dose of 5-MeO-DMT is approximately 5 mg, the third dose of 5-MeO-DMT is approximately 8 mg, or equimolar amounts of a pharmaceutically acceptable salt thereof are administered instead of 5-MeO-DMT.

[15] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[12] to

[14] above, wherein the interval between two doses is between 1 hour and 24 hours, for example, about 2 to 4 hours.

[16] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above in [9]–

[15] , the occurrence of a supreme psychedelic experience is identified by achieving at least 60% of the highest possible score on each of the four subscales of the 30-item Revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive mood, spacetime transcendence and inexpressibility), or by achieving at least 60% of the highest possible score on the Oceanic Feeling (OBN) aspect of the Altered States of Consciousness (ASC) Questionnaire, or by achieving at least the total score of the 75 Supreme Psychedelic Experiences Questionnaire (PPEQ).

[17] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in

[16] above, the occurrence of a supreme psychedelic experience is identified by achieving a total score of at least 75 supreme psychedelic experience questionnaires (PPEQ).

[18] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in any of [1] to

[17] above, administered by intramuscular injection.

[19] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[18] above, wherein a clinical response, as determined by a score of at least “marked improvement” on the Clinical Global Impression-Improvement (CGI-I) score or the Patient Global Impression-Improvement (PGI-I) score, occurs within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[20] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[19] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 6 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[21] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[20] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[22] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[21] above, wherein the clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, persists until at least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[23] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[22] above, wherein a clinical response is determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, occurring within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[24] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[23] above, wherein remission of depressive symptoms, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, occurs within approximately two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[25] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[24] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 6 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[26] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[25] above, wherein a clinical response is present on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[27] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[26] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, on the seventh day after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[28] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[27] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[29] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[28] above, wherein a clinical response is present 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[30] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[29] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[31] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[30] above, wherein the clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective score before treatment, persists until at least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

[32] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[31] above, wherein a clinical response is present 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores prior to treatment.

[33] 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in [1] to

[32] above, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Further aspects of the present invention are defined below in the section on embodiments. [Modes for carrying out the invention]

[0017] Examples of hallucinogenic drugs include tetrahedron, a cannabinoid that acts on cannabinoid receptors. Hydrocannabinol (THC), trace amine-related receptor 1 (TAAR1), and vesicles 3,4-methylenediol, an enteractogen that acts on noamine transporter 2 (VMAT2). Xymethamphetamine (MDMA, "ecstasy") and N-methyl-D-asphalt Ketamine, a dissociative anesthetic that acts as a laminate (NMDA) receptor antagonist, is one example. It can be done.

[0018] Further groups of hallucinogens include lysergic acid diethylamide (LSD), psilocybin and 5-hydroxytryptamine (5-H) such as N,N-dimethyltryptamine (DMT) T) receptors or serotonin receptors (7 families of 5-HT1 to 5-HT7 and 14 Examples include compounds that bind to the species subtype. These agonists are often referred to as "classic hallucinogens" or "psychedelic drugs," and this is Euphoria, trance, transcendence of space and time, spiritual experiences, breakdown of self-boundaries, or even near-death experiences. This emphasizes their primary ability to induce qualitative alterations in states of consciousness, such as sedation. Other effects, such as coma or hyperstimulation, are minimal.

[0019] Chemically, serotonergic psychedelic drugs are phenylalkylamines or phenylalkylamines. It is one of the doleamines, and the indoleamine class is ergoline and tryptamine It is divided into two subsets, the latter of which is given by the following formula:

[0020] [ka]

[0021] It is derived from tryptamine, which contains [a specific compound / component].

[0022] Various serotonergic psychedelic drugs affect various serotonin receptors, particularly 5-HT receptors. It has different binding affinity and activation ability for 1A, 5-HT2A, and 5-HT2C. Their activity also targets other targets such as monoamine transporters and trace amine-related receptors. It may be modulated by the interaction of these factors.

[0023] Tryptase found in the South American shrub Psychotria viridis DMT, a type of amine, or syrup, a tryptamine found in over 200 mushroom species. Cyvin, or phenylalanine found in the Uva cactus of the southwestern United States and northern Mexico Naturally occurring psychedelic drugs such as mescaline, a luquilamine, are used in indigenous cultures. It has been used for centuries in ritualistic or socio-cultural contexts, and in religious communion contexts. The use of naturally occurring psychedelic drugs in these environments is considered an unspecified "healing" "These have been considered to be due to their potential, but their potential therapeutic applications for established disease entities" More scientific investigations into this were first explored after the discovery of synthetic ergoline LSD in 1943. .

[0024] These early clinical experiences from the 1950s and 1960s were still relatively methodologically limited. Although the data was weak, promising data showed that, for example, patients who were given LSD along with psychotherapy showed cardiac Treatment programs for alcohol dependence showed higher rates of moderation or improvement than patients who received only physical therapy. Gram (Jensen SE, QJ Stud Alcohol. 1962; 23:315-20), or supplement to psychotherapy. By administering LSD as an adjunct, over 90% of patients showed "marked improvement" or "improvement." Observation of patients with personality trait confusion or anxiety who obtained the outcome of " (MacLean JR e (t al., QJ Stud Alcohol. 1961; 22:34-45), or approximately 3 minutes in patients treated with LSD. Treatment of patients with terminal cancer in which the following two conditions improved to varying degrees (Pahnke WN et al., Ps ychedelic drugs. Proceedings of a Hahnemann Medical College and Hospital Symposia um. Editors: Richard E. Hicks, Paul Jay Fink, Van Buren O. Hammett. Grune & Stra This was reported in tton, New York / London 1969, pp.33-42.

[0025] With the emergence of knowledge about the serotonin system and its role in brain function, researchers And more and more molecular activities of psychedelic drugs are being identified. However, that activity It remains somewhat unclear how this translates into the observed therapeutic effects in mental disorders. Two main concepts were proposed: the first concept was named "psycholistic therapy." Therefore, it is believed that psychedelic drugs administered at low doses promote the relaxation of psychological defense mechanisms, This, when combined with psychotherapy, leads to deep introspective insight and trauma recovery, and subsequently... It emphasized the ability to make the resulting catharsis possible. Therefore, psychology The basic mechanism considered in the combined psychotherapy approach is the activation and deepening of the combined psychotherapy process. Yes, and this required multiple drugs and treatment sessions. The second concept is "psychedelic This was named "derrick therapy," and it involves administering psychedelic drugs in high single doses. It emphasized the ability to induce a "supreme psychedelic experience." A supreme experience is the main It is characterized by the loss of judgment regarding space and time and the collapse of the boundaries of the self, and this is many In this case, a state of bliss, and the feeling of being a complete and harmonious being within the unity of the universe. This leads to experience. Therefore, the basic mechanism considered in the psychedelic approach is psychological. An intuitive perception of integrity and harmony, followed by self-improvement and increased joy of living. And it was meant to bring about a unique and overwhelming experience accompanied by a sense of inner peace.

[0026] Scientific research on the use of psychedelic drugs for the treatment of mental disorders began in the 1960s. Although it developed, the recreational use of these substances also spread rapidly, and psychedelic drugs quickly became mainstream. It was described in the media as an extremely dangerous drug to abuse. It was recognized as a threat to social order. As a result of this awareness, the U.S. Controlled Substances Act of 1970 was passed, and based on this, LSD and other psychedelic drugs Derrick drugs include the most controlled drugs, including those that have no medical use and are considered to have a high potential for abuse. It was classified into the limited category of Schedule 1. For the next 30 years, psychedelic Only very little progress has been made regarding the possible therapeutic use of derrick drugs.

[0027] In recent years, interest in the field of psychedelic therapy has finally begun to rise again. For example, anxiety and / or very low levels of psilocybin in 51 cancer patients with mood symptoms In a randomized, double-blind, crossover trial comparing a single dose similar to sevofibrillator (SEVEN) with a high single dose, At high doses, clinical indicators and self-assessments of depression, anxiety, or mood disturbances were observed 5 weeks after treatment. This resulted in a significant decrease in the indicators and an increase in the quality of life indicators, and these effects lasted for 6 months. It persisted at that point (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181- 1197). A single dose of silobicin and in 29 cancer patients with anxiety and depression In another randomized, double-blind, crossover trial of niacin as a comparator, silosibirs This has resulted in immediate and substantial improvement in anxiety and depression, as well as cancer-related morale loss. Loss and feelings of despair decreased, quality of life improved, and the effects were sustained at a 6.5-month follow-up. It was accompanied by fruit (Ross S et al., J Psychopharmacol. 2016; 30(12):1165-1180). Shirobishi Further positive experiences with treatment-resistant depression (defined in detail in the study) In an open-label study, 20 patients were administered low and high doses of silobicin with a 7-day interval between doses. This occurred in the Luarm feasibility study, and in this trial, at 1 week and 5 weeks after the procedure... Depressive symptoms were significantly reduced from baseline (Carhart-Harris RL et al., Lancet Psy). chiatry. 2016; 3(7):619-27; Carhart-Harris RL et al., Psychopharmacology (Berl). 2018; 235(2):399-408). Psilocybin is used for obsessive-compulsive disorder (Moreno FA et al., J Clin Psyc hiatry. 2006; 67(11):1735-40) and alcohol dependence (Bogenschutz MP et al., JP Sychopharmacol. 2015; 29(3):289-99) and Tobacco Dependence (Johnson MW et al., J Psy chopharmacol. 2014; 28(11):983-92; Johnson MW et al., Am J Drug Alcohol Abuse. 2 It has also been shown to be promising in the treatment of 017; 43(1):55-60). Furthermore, serotonin Regarding the psychedelic drug LSD, 1 In a double-blind, randomized, active placebo-controlled pilot study involving two patients, the following two-month period was observed. Follow-up has been reported to have a significant effect on anxiety indicators (Gasser P et al., JN erv Ment Dis. 2014; 202(7):513-20). Also, monoamine oxidase (MAO) inhibitors Contains the psychoactive agent DMT in combination with certain harmine, harmanine, and tetrahydroharmine. Regarding the shamanistic tea ayahuasca, treatment-resistant major depression (defined in detail in the study) Randomized, double-blind, placebo-versus-all single-dose session in 35 patients with (presumably) In comparative trials, a rapid antidepressant effect was demonstrated compared to placebo (Palhano-Fontes F et al.). al., bioRxiv 103531. 2017; doi: https: / / doi.org / 10.1101 / 103531).

[0028] Based on these results, the inventors believe that the administration of certain serotonergic psychedelic drugs is We believe this has demonstrated that it could be a promising approach for treating various mental disorders. However, at present, no efficacy and safety studies that meet regulatory standards have been conducted, and Psychedelic drugs are not approved by any regulatory authority. Furthermore, currently According to available data, none of the tested drugs achieved remission in all patients. Furthermore, some patients may lose their response after achieving remission, and the drugs tested... It is clear that it still has the problem of associated side effects. Also, for therapeutic use The acute psychedelic effect after oral administration of currently proposed psychedelic drugs lasts for several hours. Furthermore, this is inconvenient for patients and providers and imposes significant limitations on their practical use. For example, treatment resistance published by Carhart-Harris et al. In a study of psilocybin in depression (defined in detail in the research), among 20 patients... Nine patients showed a response at 5 weeks, but three relapsed by 6 months, experiencing anxiety, headaches, and other symptoms. Psychological side effects are frequently reported, along with the acute psychedelic effect of psilocybin lasting approximately 5-6 hours. Based on the duration, monitoring for at least 7 hours after drug administration was required (Ca rhart-Harris RL et al., Lancet Psychiatry. 2016; 3(7):619-27; Carhart-Harris RL et al, Psychopharmacology (Berl). 2018; 235(2):399-408). In addition, currently available Compared to other treatments and currently studied psychedelic drugs, the duration of psychedelic effects is... It is beneficial not only for the duration of action to be shortened, but also for the clinical response to manifest more rapidly. It has been suggested that the mental disorders in this department are, in principle, responsive to treatment with psychedelic drugs. Specific disease entities and specific subgroups of disease entities have not yet been identified. Therefore, the object of the present invention is to provide a treatment that is more effective than previously described treatments (i.e., (a) clinical a) A higher percentage of patients experience a bed response, b) A greater mean clinical response, c d) improved psychoactive therapy in which clinical response occurs earlier and clinical response is more sustained. To provide compounds for the law, as well as drug regimens and routes of administration for such therapies. The further objective of the present invention is to provide a better safety profile than previously described treatments. Compounds for improved psychoactive therapy that have a file and / or are well-tolerated. Furthermore, the aim is to provide drug regimens and routes of administration for such therapies. Another objective of Ming was to develop compounds for simpler and improved psychoactive therapies, as well as such The present invention provides drug regimens and routes of administration for therapy. Another object of the present invention is This treatment is associated with higher patient compliance rates than previously described treatments (including higher treatment initiation rates). (m) Compounds for improved psychoactive therapy and drug regimens for such therapies The present invention also aims to provide a route of administration. Certain disease entities and specific subgroups of disease entities that benefit from psychoactive therapies. The goal is to identify the specifics.

[0029] Mental disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. Currently available for body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse Treatment often involves a limited or insufficient treatment response, a delayed response, and prolonged drug administration. Side effects that limit administration, and in many cases, undesirable medications that limit patient compliance. It is insufficient for the regimen.

[0030] Some of these mental disorders are caused by LSD, psilocybin, and DMT (shamanistic tea ayawa). Recently published cases involving serotonergic psychedelic drugs such as suka Clinical studies suggest that these compounds may be alternatives to currently available treatments. This suggests that... However, even with these drugs, not all patients respond. However, some patients lose their response over time and experience certain side effects. Furthermore, current treatments The acute psychoactive effects of compounds tested to date, based on drug regimens and routes of administration, are The effects last for several hours after administration, which poses a significant problem in terms of implementation and convenience. Furthermore, these compounds... The manifestation of clinical responses by this method is, for example, in highly symptomatic patients or those at imminent risk of suicide. The treatment of patients with active suicidal ideation accompanied by the intention to carry it out requires sufficient rapid action. No. Finally, some indications are, in principle, those of these serotonergic psychedelics. It has been shown to be responsive to treatment by, but specific disease entities and specific symptoms of disease entities The group has not yet been identified.

[0031] Therefore, the technical problem solved by the present invention is that of patients with mental disorders in a broad sense. This proposes improved psychoactive therapy based on the application of serotonergic psychedelic drugs in [the field]. The technical problem is determining the responsiveness to treatment with such improved therapies. This further encompasses the identification of mental disorders and subgroups of mental disorders.

[0032] Most serotonergic psychedelic drugs work primarily through the 5-HT2A receptor. These are thought to mediate the psychoactive effects, but other receptors also play a role, and complete Pharmacology is somewhat complex. Moreover, the relationship between various mental states and specific 5-HT receptor systems is unclear. Since no correlation exists, which specific receptor affinity profile of psychedelic drugs is most... It is not easy to predict whether it will produce the desired therapeutic effect.

[0033] The inventors have discovered that the peak psychedelic state in the acute phase after administration of certain psychedelic drugs The occurrence of the trial is a surrogate behavioral marker for an unknown therapeutic mechanism that is causally or at least underlying. It was recognized that promoting the therapeutic benefits would be one of the following.

[0034] The inventors believe that the relationship between the type and intensity of psychedelic experiences is such that, for example, life-threatening cancer may be present. This is supported by research on depression and anxiety in patients, and in this trial According to Griffiths et al., the nerves immediately after the session following psilocybin administration... The confidential experience score showed a strong correlation with various treatment outcome measures after 5 weeks. This has been reported (Griffiths RR et al., J Psychopharmacol. 2016; 30(12):1181-1197). Furthermore, in cancer patients with anxiety and depression, as reported by Ross et al. Comparative studies have shown that the intensity of subjective mystical experiences during drug exposure is significantly related to clinical benefit. (For example, it was found that there was a causal relationship) (Ross S et al., J Psychopharmacol) . 2016; 30(12):1165-1180). Treatment-resistant depression (defined in detail in the study) In Rosibin's research, the Oceanic Feeling (OBN) (a mystical kind of experience, such as oneness and bliss) (Sharing the experience and characteristics of the state) but the more comprehensive visual and auditory effects of psilocybin However, it was found to have significantly higher predictive power in reducing depressive symptoms (Roseman L et al., Front Pharmacol. 2018; 8:974). Furthermore, according to Bogenschutz et al. In the study of psilocybin in alcohol dependence, the first psilocybin session The intensity of the effect was found to be highly predictive of changes in alcohol consumption during weeks 5-8. (Bogenschutz MP et al., J Psychopharmacol. 2015; 29(3):289-99). Also, John A study by Son et al. on tobacco addiction showed that those who did not smoke after 6 months Those who experienced a relapse showed a significantly higher score on the index of mystical experiences caused by psilocybin compared to those who did not. (Johnson MW et al., J Psychopharmacol. 2014; 28(11):983-92; Garcia- Romeu A, Curr Drug Abuse Rev. 2014;7(3):157-64). In early research on psychedelic drugs, Observations of this kind have already been made, and in this study, for example, alcohol treated with LSD Among those with alcohol addiction, "50 percent showed a change [that is, they stopped drinking]." Or it improved significantly... In principle, no change was seen in those who had not had transcendent experiences. They continue to drink. However, a significant change is observed in the high percentage of those who have had transcendent experiences. This was reported (citation from Unger SM, Psychiatry. 1963; 26:111-25). In fact, these early This experience further developed the concept of "psychedelic therapy" discussed earlier.

[0035] The inventors have developed a method for long-term clinical improvement in such widespread mental states using acute psychedelia. The main role of the type and intensity of the learning experience is through the so-called resting-state network (RSN). This can be explained by recent observations of the functional connectivity (FC) of the human brain. These RSNs have been shown to be responsible for various aspects of complex cognitive functions, and These interconnected networks are associated with mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety disorders. Harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse Furthermore, these conditions may be disrupted in patients who have suicidal ideation, which can occur concurrently with these diseases. It has been discovered.

[0036] The inventors believe that the breakdown of the normal hierarchical structure of RSN is the ultimate common pathway for these diseases. This may explain why many of the diseases involved can occur simultaneously in the same patient. It is believed that there is a possibility. The inventors of the present invention a) psychedelic drugs such as psilocybin, LSD and DMT The administration of cytotoxic drugs can lead to a reduction in binding within specific RSNs (Carhartt-Harr). is RL et al., Sci Rep. 2017; 7(1):13187; Palhano-Fontes F et al., PLoS One. 2015 ; 10(2):e0118143; Carhart-Harris RL et al., Proc Natl Acad Sci US A. 2016; 113( 17):4853-8), b) This decrease in the bond correlates with the rating of the peak experience (Carhart-Harris RL et a l., Sci Rep. 2017;7(1):13187; Carhart-Harris RL et al., Proc Natl Acad Sci USA . 2016; 113(17):4853-8), c) Reorganization of specific RSN activities after a peak experience (or normal An increase in (chemical) may be observed (Carhart-Harris RL et al., Sci Rep. 2017; 7(1): 13187), this correlates with d) treatment response (Carhart-Harris RL et al., Sci Rep. 2017; Further instruction (7(1):13187) suggests that the type and intensity of the acute psychedelic experience may be therapeutic. This is thought to explain the observation that it correlates with Utcam.

[0037] The inventors believe that the occurrence of a peak experience is an important mechanism or minor mechanism of the therapeutic efficacy of psychedelic drugs. At the very least, it was recognized that it serves as a surrogate behavior marker for the underlying mechanism. Therefore, the inventor The ultimate experience was achieved with previously tested psychedelic drugs and their drug regimens and Compared to other routes of administration, it is more rapid, presents in a higher percentage of patients, and provides better individual results. It is recognized that achieving this with actual results leads to a better treatment profile. I realized it.

[0038] The inventors of this invention use 5-MeO-DMT (see formula below) to induce a supreme experience. The tendency is greater than that of serotonergic psychedelic drugs previously studied for the treatment of neurological disorders. It was identified as a highly serotonergic psychedelic drug, and further based on 5-MeO-DMT... The highest experience is the breakdown of the ego's boundaries and the more frequent the experience of bliss and / or oneness. The inventors recognized that this is associated with frequent use. The inventors also stated that 5-MeO-DMT is for the treatment of neurological disorders. Therefore, it can induce a peak experience more rapidly than previously studied serotonergic psychedelic drugs. The inventors recognized that the duration of psychedelic experiences is shorter. These characteristics of MT are associated with an improved treatment profile and are based on 5-MeO-DMT treatment. We believe this can be explained by specific changes in RSN activity.

[0039] [ka]

[0040] In one embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety disorders. Harm, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse Regarding the use of therapeutically effective doses of 5-MeO-DMT in the treatment of such disorders. The use of therapeutically effective doses of 5-MeO-DMT in such cases is effective for treating disorders and suicidal ideation. This includes the use of therapeutically effective doses of 5-MeO-DMT in patients with suicidal ideation. Treatment in patients with such disorder, including use in patients with treatment-resistant disorder This includes the use of therapeutically effective doses of 5-MeO-DMT. All of these conditions disrupt the activity of the RSN. It is known that this is related to disturbances, and the inventors of this invention have found that this invention can eliminate these conditions using 5-MeO-DM We recognized that T should be responsive to treatment.

[0041] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. The use of a therapeutically effective dose of 5-MeO-DMT in the treatment thereof, thereby achieving a clinical response This relates to the use that is rapidly achieved after administration of 5-MeO-DMT.

[0042] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. The use of a therapeutically effective dose of 5-MeO-DMT in the treatment thereof, thereby achieving a clinical response This concerns the long-term use of 5-MeO-DMT after administration.

[0043] In another embodiment, the present invention relates to mental disorders, particularly major depressive disorder, persistent depressive disorder, and anxiety. Disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. Novel dosing regimens and routes of administration of 5-MeO-DMT for use in the treatment of [specific condition] Therefore, achieving a supreme experience with good reproducibility within the same patient, and in a high proportion of patients. Regarding novel drug regimens and routes of administration that enable high peak experience rates and results. In addition to enabling improvements in the therapeutic effects that result from these new drug regimens and The proposed plan also reduces the risk of over-medication, thereby improving the safety profile. Such improved drug regimens increase with subsequent doses on the same day or the following day. It depends on applying the same dose of 5-MeO-DMT to the same patient. The route of administration depends on intravenous, intramuscular, or subcutaneous administration of 5-MeO-DMT.

[0044] Through each of these embodiments, and especially through combinations thereof, the present invention 1) Improved psychoactive therapy based on the application of psychedelic drugs to patients with mental disorders 1) Provide a method, and 2) certain psychiatric conditions that are responsive to treatment by such improved therapies. This solves the problem of identifying specific subgroups of psychiatric and mental disorders.

[0045] 5-MeO-DMT has a short duration of acute psychedelic effects (for example, oral syrup). Despite (5-20 minutes after intravenous injection, compared to several hours for sibin and oral LSD) The fact that it has improved therapeutic effects is surprising, but the short duration of this effect is actually... and the absence of associated tolerability (i.e., reduced psychedelic effect after readmission or The absence of loss increases the occurrence rate of peak experiences, thereby increasing therapeutic benefits. Novel drug regimens designed for frequent re-dosing (more than once a day, or daily, etc.) This is the basis for making men possible. Repeated administration within such a short period of time also leads to overdose. It enables intra-individual dose optimization to reduce risk, otherwise, serotonin syndrome, Physical side effects such as negative psychological reactions like flashbacks of the experience at a later point in time, or changes If you have little or no memory of sexual activity (so-called "whiteout"), the significance is It can produce a less psychedelic experience. Furthermore, by starting with a low dose, patients Generally, they become accustomed to psychedelic experiences, and stronger symptoms occur at higher doses. This allows for preparation, which positively impacts the experience at these higher doses. The prospect of being able to start treatment with a low dose is a positive development for patients regarding treatment approaches. This encourages approval and improves overall compliance rates at the patient population level.

[0046] To increase the rate of peak experience and adjust the reproducibility of peak experience, as well as to improve therapeutic effects. Therefore, serotonin production is aimed at reducing side effects and improving compliance rates. Frequent readmission of oral psychedelic drugs was not intended in the prior art, and in practice, readmission has occurred. If the psychedelic effects observed with those current drug regimens and routes of administration are delayed Furthermore, due to its long duration and tolerability that can last for several days (i.e., psychedelic after re-administration) Due to the rapid onset of the derrick effect (reduction or loss) for other psychedelic drugs This may not be possible with the currently tested dosing regimens. The previously described dosing regimens for psychedelic drugs are either single doses or multiple doses. The plan was to administer the drug only once every few days, or to administer it orally only. Therefore, in these currently applied drug regimens and routes of administration, the highest experience is reliable. This is not achieved, and these regimens do not yield the additional benefits mentioned above.

[0047] Intravenous, intramuscular, or subcutaneous administration of 5-MeO-DMT offers high bioavailability. Furthermore, the small variability in bioavailability between patients and between re-administrations in the same patient. To enable this, it allows for a supreme experience with high efficiency and high reproducibility. Furthermore, intravenous, Intramuscular or subcutaneous administration is performed by inhalation or intranasal infusion in at least some patients. It is considered simpler and more tolerable compared to other methods, and can be administered intravenously, intramuscularly, or Subcutaneous administration is preferred by at least some physicians due to its ease of use. Furthermore, Intravascular, intramuscular, or subcutaneous administration may result in a physician or other medical professional being required when administered by inhalation. Avoid exposure of healthcare providers to 5-MeO-DMT.

[0048] 5-MeO-DMT acts as a 5-HT1A and 5-HT2A receptor agonist. It is tryptamine, a naturally occurring serotonergic psychedelic drug. 5-M eO-DMT was first discovered in Dictyoloma incanescens. Although isolated from tree bark, it is also found in other plants, including the Colorado River toad (Bufo alvar). It has been identified as the main active ingredient in the venom of *Ius toad*. Furthermore, 5-MeO-DMT It is synthesized in the human pineal gland and retina and is found in human bodily fluids, including urine, blood, and cerebrospinal fluid. It is released. 5-MeO-DMT is mainly mediated by monoamine oxidase A. It is inactivated by the amination pathway and the cytochrome P450 2D6 (CYP2D6) enzyme. It is O-demethylated by and produces the active metabolite bufotenin. It binds to the 5-HT2A receptor with a much higher affinity than 5-MeO-DMT itself. do.

[0049] A composition containing 5-MeO-DMT in addition to 5-MeO-DMT and other active components. It has previously only been used in ceremonial or recreational settings (erowid.org / chemicals / 5meo_dmt / 5meo_dmt_dose.shtml and erowid.org / chemicals / 5meo_dmt / 5meo_dmt_effect (s.shtml, accessed March 1, 2018). 5-MeO-DMT and other active components In addition, usage patterns, intake motivations, and main factors related to the use of compositions containing 5-MeO-DMT. Recent internet studies aimed at examining the effects, potential benefits, and outcomes The survey revealed that self-reported conditions including anxiety, depression, substance use problems, and post-traumatic stress disorder were present. The majority of respondents with psychological conditions reported an improvement in symptoms related to these disorders. This was explained (Davis AK et al., J Psychopharmacol. 2018 Jul;32(7):779-792). However, As described by the authors, "This study is a cross-sectional study and does not verify psychological symptoms." It lacks established indicators and assessments of past psychological treatments, and includes many multi-substance users. Therefore, causal inference regarding the relationship between the use of 5-MeO-DMT and symptom improvement is limited. Therefore, the relevance of psychological benefits remains observational."

[0050] The application of 5-MeO-DMT in combination with MAO inhibitors enhances and prolongs the drug effect. It can bring about positive effects, but also potentially more toxicity. It is most commonly described in ritual or recreational settings. The administration route for 5-MeO-DMT is inhalation of smoke or vapor or intranasal infusion. However, other routes such as intravenous, rectal, or oral administration are also described, and via the latter route Absorption is likely due to a substantial first-pass effect resulting from the rapid action of MAO enzymes in the intestines and liver. It is restricted by.

[0051] Advantageous effects of the invention The beneficial effects of this invention compared to current standard treatments for each indication include: While not limited to these, a) a higher percentage of patients experiencing a clinical response, b) more a) High average clinical response, c) Onset earlier than clinical response, d) Longer-lasting clinical response, e) Less Similar or better clinical response with no or different side effects, and therefore improvement. Improved compliance, as well as f) simpler treatment regimens including fewer drug doses Equivalent or better clinical responses, and resulting improved compliance, are among the benefits. Compared to previously studied psychedelic drugs, the present invention provides, for example, g) rapid post-administration effects. Equivalent or better clinical response with a shorter duration of psychoactive effects, resulting in improvement Improved convenience and compliance, h) tendency to achieve the ultimate psychedelic experience The greater the reproducibility of achieving the ultimate psychedelic experience, and at the same time, unnecessary To avoid high doses and associated side effects, and to achieve better tolerability, and therefore improve Further providing improved medication regimens and routes of administration with better compliance. Furthermore, the beneficial effects are particularly pronounced in patients who are resistant to treatment as defined herein. It is noted that this should be achieved.

[0052] definition When used in the context of the present invention, unless otherwise stated, "5-MeO-DMT" The term refers to the free base 5-MeO-DMT. The pharmaceutically acceptable status of 5-MeO-DMT is... The salts that are accepted are also typically intended for use. An example of such a salt is hydrochloride. The appropriate weight of salt to be administered is calculated from the weight of the free base, assuming that equimolar amounts are used. It may also be used.

[0053] When used in the context of the present invention, the “patient” being treated is the “accepted medical procedure.” The subjects are individuals diagnosed with major depressive disorder by a qualified professional. The diagnosis is, for example, In accordance with the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) published by the American Psychiatric Association i, mental disorders, especially major depressive disorder, persistent depressive disorder, anxiety disorders, post-traumatic stress disorder They may be said to suffer from harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder, or psychoactive substance abuse. The diagnosis is made by a physician or psychologist. The human subject themselves identifies one of the disorders. It is insufficient to consider them to be suffering from one of these conditions.

[0054] When used in the context of this invention, "suicidal ideation" means thinking, considering, or planning to commit suicide. This refers to the presence of suicidal ideation in a patient, which is an established professional tool for diagnosing suicidal tendencies. Diagnosis is made by a physician or psychologist using a protocol and method. The patient themselves... It is generally insufficient to consider someone as suffering from suicidal ideation. In some situations, experiencing suicidal ideation is... Patients who do this are considered to be at imminent risk of suicide or to have the "intention to do so". It will be done.

[0055] When used in the context of the present invention, unless otherwise stated, "to treat" and "to treat" The term "treatment" refers to the management of a patient aimed at combating a disease, condition, or disorder. Including care and / or relief of signs and / or symptoms, or disease, condition or disorder The present invention includes the administration and methods of compounds for eliminating the disease.

[0056] When used in the context of the present invention, unless otherwise stated, the term “therapeutic effective dose” refers to the same term. , including the alleviation of signs and / or symptoms of the disease, condition or disorder being treated, researchers , a biological or clinical response pursued by a medical doctor or other clinician in humans This refers to the amount of active compound or pharmaceutical ingredient that induces a reaction.

[0057] "Clinical response" is not limited to these, but also includes the Clinical Global Impression-Severity Scale (CGI-S ), Patient Global Impression-Severity Scale (PGI-S), Clinical Global Impression-Improvement Scale ( The rating scales include the CGI-I or the Patient Global Impression-Improvement Scale (PGI-I). This includes, but is not limited to, improvements in major depressive disorder and persistent depressive disorder. The Montgomery-Asberg Depression Rating Scale (MADRS) or the 17-item Hami Measured by the Luton Depression Rating Scale (HAM-D), for example, the Beck Anxiety Scale (BAI). Hamilton Anxiety Scale (HAM-A) or state-characteristics for anxiety symptoms and anxiety disorders. Anxiety assessment (STAI), post-traumatic stress disorder clinical diagnostic interview. The Capsule Action Scale (CAPS), modified for Body Dysmorphic Disorder (Ale-B) The Rowon College Obsessive-Compulsive Disorder Rating Scale (BDD-YBOCS), and a report on obsessive-compulsive disorder. Brown University Obsessive-Compulsive Disorder Rating Scale (Y-BOCS), weight gain in anorexia nervosa. In addition, the frequency of binge eating and vomiting episodes in bulimia nervosa, and the frequency of binge eating episodes in bulimia nervosa. The frequency of swords, the duration of restraint or reduction of substance use in psychoactive substance abuse, and Suicidal ideation and suicidal ideation are assessed using suicidal tendency assessments such as the Columbia Suicide Severity Rating Scale (C-SSRS). Fixed scale or MADRS suicidal thought items, or Clinical Global Impression Severity of Suicidal Tendency - Revised Revised (CGI-SS-R) scale (CGI-SS-R is derived from CGI-S, where 0 = normal, not at all) 1 = No suicidal tendencies, 2 = Mild suicidal tendencies, 3 = Moderate suicidal tendencies (4 = significant suicidal tendency, 5 = severe suicidal tendency, 6 = extreme suicidal tendency) Further endpoints include longer recall periods (e.g., typically 7 days in MADRS). Based on endpoints developed for the period between drug administration, an early point in time (e.g., 2 hours) is measured. When determining clinical response using ) a reasonable modification of such endpoints (e.g., MA) The DRS recall period was changed to 2 hours, and the sleep items recorded at baseline before drug administration were changed. The carry-over rule may also be applied.

[0058] When used in the context of the present invention, unless otherwise stated, "administration" (or "application") The term refers to the distribution of an active compound or pharmaceutical ingredient in any amount, which may be a predetermined quantity, through any pathway. This means introducing the drug to the patient. The active compound is administered intravenously or intramuscularly. It is administered by hand or subcutaneously.

[0059] When used in the context of the present invention, unless otherwise stated, "dose" and "administration amount" are used. The term "dosage" refers to the amount of the active compound or pharmaceutical ingredient administered to a patient in each individual dose. It means the amount. The term "dosage regimen" (or "medication regimen") means one or This refers to a predetermined sequence of multiple individual doses.

[0060] Embodiments of the present invention The present invention provides a therapeutically effective dose of 5-MeO-DMT or pharmaceutically effective dose to a patient as defined herein. This includes administering the salt that is tolerable to mental disorders, particularly major depressive disorder and persistent depression. Pathological disorders, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and This concerns improved methods for treating psychoactive substance abuse. Treatment of these disorders is: This definition of having such disorders and suicidal ideation is not limited to those defined herein. This includes the use of 5-MeO-DMT or pharmaceutically acceptable salts thereof in patients. Treatment of the disorder is particularly important for patients as defined herein who have the treatment-resistant disorder mentioned. This includes the use of 5-MeO-DMT or a pharmaceutically acceptable salt thereof in the present invention. When used in relation to pulse, "treatment-resistant" is used in major depressive disorder and persistent depressive disorder. for at least two appropriate courses of pharmacological treatment in the current depressive episode Defined as lacking adequate improvement, anxiety disorders, post-traumatic stress disorder, body dysmorphic disorder and In obsessive-compulsive disorder, at least one appropriate course of pharmacological treatment and at least one psychotherapy session are necessary. It is also defined as a lack of appropriate improvement for a single appropriate process, as well as eating disorders and Psychoactive substance abuse requires at least one appropriate psychotherapy session, with or without pharmacological treatment. It is defined as the absence of appropriate improvement after a thorough process. Whether the improvement is appropriate depends on the clinical assessment. The answer is judged, and whether the treatment process is appropriate is determined by the regimen, dosage, duration, and Compliance is assessed. Appropriateness is determined by a set of predetermined criteria, and by the physician. This is determined and recorded by a psychologist, and the patient themselves may feel that their past treatment process was inappropriate. It is not sufficient to consider that one has not responded appropriately. Appropriateness is retrospective and It may be judged positively.

[0061] Treatment for patients with anxiety disorders includes, but is not limited to, panic disorder and phobias. This includes patients with anxiety disorders, social anxiety disorder, and generalized anxiety disorder. It also includes patients with eating disorders. Treatment for patients with anorexia nervosa, bulimia nervosa, and bulimia nervosa is not limited to these, but is not limited to these. This includes sexual disorders. Treatment of patients with substance abuse includes, but is not limited to, alcohol Related disorders, opioid-related disorders, sedative, hypnotic or anxiolytic-related disorders, cocaine-related disorders This includes patients with disorders, other stimulant-related disorders, and nicotine dependence.

[0062] The disorders preferably treated by the present invention include major depressive disorders, including treatment-resistant types thereof. These include generalized anxiety disorder, obsessive-compulsive disorder, and anorexia nervosa. The present invention most preferably... The disorders that are treated include major depressive disorder, including treatment-resistant forms, and suicidal ideation. This includes patients with major depressive disorder who have [specific characteristic].

[0063] In the embodiment, these disorders include treatment-resistant disorders, as well as these disorders accompanied by suicidal ideation. Mental disorders, particularly major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This specification includes, but is not limited to, harm, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse. The dosage of 5-MeO-DMT administered to defined patients is in the range of approximately 1 mg to 10 mg. Any amount within the range or area. Useful specific amounts include, for example, about 1 mg, about 2 mg. Approximately 3 mg, approximately 4 mg, approximately 5 mg, approximately 6 mg, approximately 7 mg, approximately 8 mg, approximately 9 mg and approximately 1 It is 0 mg. A pharmaceutically acceptable salt of 5-MeO-DMT is preferably used in this embodiment. The appropriate weight of salt to be used and administered is given by assuming equimolar amounts of free base. It is understood that it may be calculated from the weight.

[0064] In this specification, when a range such as "approximately 1 mg to approximately 10 mg" is described, the inventors of this invention Some of them will be mentioned in detail, but the intention is to consider all individual values ​​within that range, Please note that for the sake of brevity, not all of them will be mentioned.

[0065] In preferred embodiments, these disorders include treatment-resistant disorders and those associated with suicidal ideation. Mental disorders such as disabilities, especially major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This person has Tress syndrome, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. Improved method for treating patients as defined in the specification with a therapeutically effective dose of 5-MeO-DMT The method involves the occurrence of a clinical response within approximately two hours after administration of 5-MeO-DMT.

[0066] In preferred embodiments, these disorders, including treatment-resistant disorders, and these disorders associated with suicidal ideation. Mental disorders such as major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This specification includes the following: schizophrenia, body dysmorphic disorder, obsessive-compulsive disorder, eating disorder, and psychoactive substance abuse. Improved method for treating patients as defined in the book with a therapeutically effective dose of 5-MeO-DMT This includes clinical responses that occurred within approximately 2 hours after administration of 5-MeO-DMT. Until at least about 6 days after the last dose of DMT, preferably the last dose of 5-MeO-DMT. Up to at least about 14 days after administration, more preferably the last dose of 5-MeO-DMT This includes, at least, sustained clinical response for up to approximately 28 days.

[0067] In preferred embodiments, these disorders include treatment-resistant disorders and are accompanied by suicidal ideation. Mental disorders including major depressive disorder, persistent depressive disorder, anxiety disorders, and post-traumatic stress disorder. This person has Tress syndrome, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders, and psychoactive substance abuse. Improved method for treating patients as defined in the specification with a therapeutically effective dose of 5-MeO-DMT The method involves administering doses greater than a single dose of 5-MeO-DMT.

[0068] In a preferred embodiment, a dose greater than a single dose of this 5-MeO-DMT is 1 or It is administered to the patient in multiple treatment blocks, each block consisting of 2 to 7 doses, and each treatment The interval between each administration within a block is approximately 1 hour to 24 hours, and the end of one treatment block. The interval between the completion of one treatment block and the start of the next treatment block is approximately 6 days or more.

[0069] In a more preferred embodiment, a larger dose of this 5-MeO-DMT than a single dose It is administered to the patient in one or more treatment blocks, each block consisting of 1 to 3 doses. The interval between each administration within each treatment block is approximately 24 hours, and the end of one treatment block is followed by the next. The interval between the start of the treatment block is approximately 6 days or more.

[0070] In the most preferred embodiment, a dose greater than a single dose of this 5-MeO-DMT is 1 Alternatively, it is administered to the patient in multiple treatment blocks, each block consisting of 1 to 3 doses. There is approximately 2-4 hours between each administration within a treatment block, and the end of one treatment block is followed by the next administration. The time between the start of block placement is approximately 6 days or more.

[0071] In the embodiment, each administration and each treatment block is administered to individual patients. The dosage of 5-MeO-DMT administered is constant for each individual patient, ranging from approximately 1 mg to approximately The starting dose is 10mg.

[0072] In a preferred embodiment, the dosage of 5-MeO-DMT administered to individual patients is determined by each patient. The first dose within the block is selected from approximately 1 mg to 2 mg, and then progresses to 10 mg. Either the earlier of the two, all doses within that treatment block are administered. It increases with each subsequent dose within each treatment block.

[0073] In a more preferred embodiment, the administration of 5-MeO-DMT to individual patients. The dosage is selected from approximately 1 mg to 2 mg for the first dose within each treatment block, followed by 10 The dose reaches mg, or all doses within that treatment block are administered, or the patient The individual may experience a supreme psychedelic experience, or the supervising physician may observe side effects. Each treatment until it is determined that further dose increases are inappropriate, whichever comes first. It increases with each subsequent dose within the block.

[0074] In embodiments where the dosage increases with subsequent administrations, the dosage of the next administration is equal to the dosage of the previous administration. Approximately 0.25 mg to approximately 3 mg, preferably approximately 0.5 mg to approximately 3 mg, most preferably approximately 6 It is determined by adding mg. For example, if the dosage for the first dose is 1 mg, If the dosage increase is 3 mg, unless one of the aforementioned discontinuation criteria is reached, the second The dosage for the first administration is 4 mg. Preferably, the dosage for the third administration is 7 mg.

[0075] In a preferred embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of DMT is selected from approximately 1 mg to 3 mg for the first dose, and then the patient's dosage is... Unless you have already experienced a supreme psychedelic experience within the treatment block, or if the supervising physician Unless it is determined that further dose increases are inappropriate based on observed side effects, The second dose is selected from approximately 4 mg to approximately 6 mg, and the third dose is approximately 7 The dosage is increased to a selectable amount ranging from mg to approximately 9 mg. The usefulness of the first, second, and third doses. Specific amounts include, for example, about 2 mg, about 5 mg, and about 8 mg.

[0076] In a more preferred embodiment, the administration of 5-MeO-DMT to individual patients. The dose is selected from approximately 1 mg to approximately 2 mg for the first administration of the first treatment block, and then 1 The dose reaches 0 mg, or all doses in that treatment block are administered, or The patient experiences a peak psychedelic experience, or the supervising physician observes side effects. up to the earlier of the determination that further dose increases are inappropriate. It increases with each subsequent dose within the treatment block, up to the maximum dose in the first treatment block. The dosage is for all subsequent treatment blocks and administration within those subsequent treatment blocks. It is used as the dosage. For example, the maximum dose in the first treatment block is when the patient If the dose was 8mg because it resulted in a supreme psychedelic experience, then all subsequent... The dose for administration within the treatment block and subsequent treatment blocks is 8 mg. ru.

[0077] In the most preferred embodiment, the dosage of 5-MeO-DMT administered to an individual patient is: The first dose of the first treatment block is selected from approximately 1 mg to approximately 3 mg, and then the patient... Unless you have already experienced a supreme psychedelic experience within the treatment block, or under the supervision of a physician Unless it is determined that further dose increases are inappropriate based on the observed side effects For the second dose of the first treatment block, the dosage is selected from approximately 4 mg to approximately 6 mg. For the third administration of the first treatment block, the dosage is increased to a selection of approximately 7 mg to 9 mg. In addition, the maximum dose in the first treatment block is the same as in all subsequent treatment blocks. and used as the dosage for administration within the subsequent treatment block. First treatment The useful specific doses of the first, second, and third doses in the block are, for example, about 2 mg, about The dosages are 5 mg and approximately 8 mg.

[0078] A pharmaceutically acceptable salt of 5-MeO-DMT is used in all of the above drug regimens. The appropriate weight of the salt to be preferably used and administered is, assuming that equimolar amounts are used. It is understood that this can be calculated from the stated weight of the free base.

[0079] According to the present invention, 5-MeO-DMT is preferably administered together with an MAO inhibitor. stomach.

[0080] The occurrence of "peak psychedelic experiences" in patients is determined by the 30-item revised mystical experience questionnaire. The four subscales of the MEQ30 (Mysticism, Positive Mood, Transcendence of Space and Time, and Expression) Identified by achieving at least 60% of the highest possible score in each difficulty level. This is possible (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90). The scoring items are shown in Example 4.

[0081] The occurrence of “peak psychedelic experiences” in patients is also related to altered states of consciousness (ASC) questions. Identified by achieving at least 60% of the highest possible score on the Oceanic Nation (OBN) side. This is acceptable (as described in Roseman L et al., Front Pharmacol. 2018; 8:974).

[0082] The occurrence of a "peak psychedelic experience" in patients is also related to the peak psychedelic experience question. Identified by achieving a total score of at least 75 in the PPEQ (Picks and Equivalents) score. Often, this involves the following three questions: 1. How powerful was the experience? 2. To what extent In response to the questions: 3. How profound (i.e., deep and significant) was the experience? This is the average of responses scored on a scale of 0 to 100 by each patient.

[0083] The therapeutically effective dose of 5-MeO-DMT can be administered intravenously, intramuscularly, and It is administered subcutaneously. Administration via these routes ensures a rapid onset of action. This is possible. The most preferred route of administration is via the intramuscular route, i.e., by intramuscular injection. It is given.

[0084] 5-MeO-DMT is pharmaceutically acceptable, preferably in the form of a formulation for administration by injection. It may be used as a salt, and examples of excipients and vehicles for such preparations are This is publicly known in the field of technology.

[0085] The patient may also receive psychotherapy intervention.

[0086] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. The patient may also suffer from suicidal ideation accompanied by the intention to carry it out, and the risk of suicide may be imminent. It may be considered to be in the same particular embodiment, having major depressive disorder, The dosage of 5-MeO-DMT administered to patients as defined herein is approximately 1 mg to approximately 10 mg Because the dosage is in the mg range and based on a pharmaceutically acceptable salt of 5-MeO-DMT It is administered intramuscularly in the form of a formulation containing 5-MeO-DMT, which is pharmaceutically acceptable. The weight of the salt is stated as the free base of 5-MeO-DMT, assuming equimolar amounts are used. The usefulness of 5-MeO-DMT in this particular embodiment Specific amounts include, for example, approximately 1 mg, approximately 2 mg, approximately 3 mg, approximately 4 mg, approximately 5 mg, approximately 6 mg, approximately The dosages are 7 mg, approximately 8 mg, approximately 9 mg, and approximately 10 mg.

[0087] In certain embodiments, the disorder being treated is major depressive disorder. In this particular embodiment, the patient may suffer from treatment-resistant major depressive disorder. the patient may also suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of sui cide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to a patient defined herein having major depressive disorder is in the range of about 1 mg to about 10, and for administration based on a pharmaceutically acceptable salt of 5-MeO-DMT mg, and is administered by intramuscular administration in the form of a formulation for administration based on a pharmaceutically acceptable salt of 5-MeO-DMT , wherein the weight of the pharmaceutically acceptable salt of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming an equimolar amount is used . Useful specific amounts of 5-MeO-DMT in this particular embodiment are, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg, and about 10 mg. In this same specific embodiment, the clinical response as determined by at least a 50% improvement in the MADRS or HAM-D score, or the clinical response as determined by a score of at least "marked improvement" on the CGI-I or PGI-I score , as compared to the respective scores prior to administration of 5-MeO-DMT, occurs within about 2 hours after administration of 5-MeO-DMT .

[0088] In certain embodiments, the disease to be treated is major depressive disorder. In this same specific embodiment, the patient may suffer from treatment-resistant major depressive disorder . In this same specific embodiment, the patient may also suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of sui cide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to a patient defined herein having major depressive disorder is in the range of about 1 mg to about 10 mg ​​​​in the mg range, and for administration based on a pharmaceutically acceptable salt of 5-MeO-DMT is administered by intramuscular administration in the form of a formulation, and the pharmaceutically acceptable salt weight of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming equimolar amounts are used . Useful amounts of 5-MeO-DMT in this particular embodiment are, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about 7 mg, about 8 mg, about 9 mg and about 10 mg. In this same particular embodiment, 1 remission of depressive conditions as determined by a MADRS score of 0 or less or a HAM-D score of 7 or less occurs within about 2 hours after administration of 5-MeO-DMT .

[0089] In certain embodiments, the disease to be treated is major depressive disorder. In this same particular embodimen t, the patient may suffer from treatment-resistant major depressive disorder. In this same particular embodiment , the patient may also suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide . In this same particular embodiment, the dosage of 5-MeO-DMT administered to a patient having major depressive disorder, as defined herein , ranges from about 1 mg to about 10 mg, and for administration based on a pharmaceutically acceptable salt of 5-MeO-DMT is administered by intramuscular administration in the form of a formulation, and the pharmaceutically acceptable salt weight of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming equimolar amounts are used . Useful amounts of 5-MeO-DMT in this particular embodiment are, for example, about 1 mg, about 2 mg, about 3 mg, about 4 mg, about 5 mg, about 6 mg, about These are 7 mg, approximately 8 mg, approximately 9 mg, and approximately 10 mg. In this same particular embodiment, 5 -Including clinical responses that occurred within approximately 2 hours after administration of 5-MeO-DMT Compared to the respective scores before administration, at least the MADRS or HAM-D score Clinical response, or CGI-I or PGI-I score, is determined by a 50% improvement. A clinical response judged as at least a "marked improvement" score is 5-MeO-DMT At least about 6 days after the last dose, preferably less than 6 days after the last dose of 5-MeO-DMT At least until approximately 14 days after the last dose of 5-MeO-DMT, more preferably at least It lasts for about 28 days.

[0090] In certain embodiments, the disorder being treated is major depressive disorder. In this state, the amount of 5-MeO-DMT administered to individual patients is the amount of the first treatment block. The first dose is selected from approximately 1 mg to 3 mg, and then the patient reaches the desired level within that treatment block. Unless you have already had a high-psychedelic experience, or if your supervising physician has observed any side effects Unless it is determined that further dose increases are inappropriate based on the first treatment block The second dose is selected from approximately 4 to 6 mg, and the first treatment block is The dosage for step 3 is increased to a dose selected from approximately 7 mg to approximately 9 mg, and the first treatment block The maximum dose in the block is for all subsequent treatment blocks and their subsequent treatment blocks. Used as the dosage for administration within the block. The first and second in the first treatment block. And useful specific doses for the third dose are, for example, about 2 mg, about 5 mg, and about 8 mg. In this particular embodiment, the interval between each dose within the first treatment block is approximately 3 hours. In this same particular embodiment, 5-MeO-DMT is pharmaceutically equivalent to 5-MeO-DMT. It is administered by intramuscular injection in the form of a formulation for administration based on acceptable salts, and 5-Me The pharmaceutically acceptable salt weight of O-DMT is calculated assuming equimolar amounts are used, i.e., 5-Me This may be calculated from the stated weight of the free base of O-DMT. So, the occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) Achieving at least 60% of the highest possible score in each category (Barrett FS, J Psychopharma) As described in col. 2015;29(11):1182-90, or at least 75 Supreme Psychedelia This is identified by achieving a total score on the Personal Experience Questionnaire (PPEQ).

[0091] Furthermore, in certain embodiments, the disorder being treated is major depressive disorder. In the embodiment, the dosage of 5-MeO-DMT administered to individual patients in each treatment block The dosage is selected from approximately 1 mg to 3 mg for the first dose, and then the patient uses the treatment block. Unless you have already experienced a supreme psychedelic experience within the group, or under the supervision of a physician Unless it is determined that further dose increases are inappropriate based on side effects, a second dose is given. The dosage is selected from approximately 4 mg to approximately 6 mg, and the third dose is approximately 7 mg to approximately 9 mg. The dosage is increased to a dose selected from g. The first, second and third in the first treatment block. Useful specific doses of this medication are, for example, about 2 mg, about 5 mg, and about 8 mg. In this particular embodiment, the interval between each administration within each treatment block is approximately 3 hours, and one treatment The interval between the end of a treatment block and the start of the next treatment block is about 6 days. In this same specific embodiment, 5-MeO-DMT is administered by intramuscular administration in the form of a formulation for administration based on a pharmaceutically acceptable salt of 5-MeO-DMT, and the pharmaceutically acceptable The weight of the pharmaceutically acceptable salt of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming that an equimolar amount is used. In this same specific embodiment, the occurrence of a peak psychedelic experience The weight of the pharmaceutically acceptable salt of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming that an equimolar amount is used. In this same specific embodiment, the occurrence of a peak psychedelic experience The weight of the pharmaceutically acceptable salt of 5-MeO-DMT may be calculated from the stated weight of the free base of 5-MeO-DMT, assuming that an equimolar amount is used. In this same specific embodiment, the occurrence of a peak psychedelic experience is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), or achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), or achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), or achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), or achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ). is identified by achieving at least 60% of the maximum possible score on each of the four subscales of the 30-item Revised Mystical Experience Questionnaire (MEQ30) (mystical, positive mood, transcendence of time and space, and ineffability) (as described in Barrett FS, J Psychopharmacol. 2015;29(11):1182-90), or achieving a total score of at least 75 on the Peak Psychedelic Experience Questionnaire (PPEQ).

[0092] In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m In certain embodiments, the disease to be treated is treatment-resistant major depressive disorder. In this same specific embodiment, the patient may suffer from suicidal ideation with intent to act, and may be considered to be at imminent risk of suicide. In this same specific embodiment, the dosage of 5-MeO-DMT administered to an individual patient is selected from about 1 mg to about 3 mg for the first administration of the first treatment block, and thereafter, unless the patient has already experienced a peak psychedelic experience within that treatment block, or the supervising physician has determined that further dose escalation is inappropriate based on observed side effects, the dosage is selected from about 4 mg to about 6 mg for the second administration of the first treatment block, and about 7 m The dosage is increased to a selectable amount ranging from g to approximately 9 mg, with the maximum dose in the first treatment block. The dosage is for all subsequent treatment blocks and administration within those subsequent treatment blocks. It is used as the dosage for the first, second and third administrations in the first treatment block. Useful specific amounts are, for example, about 2 mg, about 5 mg, and about 8 mg. In the administration configuration, the interval between each administration within the first treatment block is approximately 3 hours. In the embodiment, 5-MeO-DMT is based on a pharmaceutically acceptable salt of 5-MeO-DMT. It is administered by intramuscular injection in the form of a formulation for administration, and the pharmaceutical properties of 5-MeO-DMT The acceptable salt weight is the free salt of 5-MeO-DMT, assuming equimolar amounts are used. It may be calculated from the stated weight of the base. In this same particular embodiment, the supreme psychedelic The occurrence of a Rick experience is measured by four subscales of the 30-item Revised Mystical Experiences Questionnaire (MEQ30). Possible in each of (mysterious, positive mood, transcendence of space and time, and inexpressibility) Achieving at least 60% of the highest score (Barrett FS, J Psychopharmacol. 2015;29(11):1 As described in 182-90, or at least 75 Supreme Psychedelic Experience Questionnaires (P Identified by achieving a total score (PEQ).

[0093] Furthermore, in certain embodiments, the disease being treated is treatment-resistant major depressive disorder. In the same particular embodiment, 5-MeO- is administered to individual patients in each treatment block. The dosage of DMT is selected from approximately 1 mg to 3 mg for the first dose, and then the patient's dosage is... Unless you have already experienced a supreme psychedelic experience within the treatment block, or if the supervising physician Unless it is determined that further dose increases are inappropriate based on observed side effects, For the second dose, the dosage is selected from approximately 4 mg to approximately 6 mg, and for the third dose, approximately 7 mg The dosage is increased to a selected dose from g to approximately 9 mg. In the first treatment block, the first, Useful specific doses for the second and third doses are, for example, about 2 mg, about 5 mg, and about 8 mg. In this particular embodiment, the interval between each administration within each treatment block is approximately 3 hours. The interval between the end of one treatment block and the start of the next treatment block is approximately 6 days. In the same particular embodiment, 5-MeO-DMT is pharmaceutically acceptable as 5-MeO-DMT. It is administered by intramuscular injection in the form of a salt-based formulation for administration, and 5-MeO-DM The pharmaceutically acceptable salt weight of T is given by 5-MeO-DM, assuming equimolar amounts are used. It may be calculated from the stated weight of the free base of T. In this same particular embodiment, The occurrence of high-psychedelic experiences is related to four items on the 30-item Revised Mystical Experiences Questionnaire (MEQ30). Each of the subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) Achieving at least 60% of the highest possible score (Barrett FS, J Psychopharmacol. 201) As described in 5;29(11):1182-90, or at least 75 supreme psychedelic experiences Identified by achieving a total score on the questionnaire (PPEQ).

[0094] Embodiment Specific embodiments of the present invention are listed below.

[0095] The present invention, in the embodiments and claims described herein, means that "the patient is treated." 5-methoxy-N,N-dimethyltryptamine (5MeO-DMT) for use in Change phrases such as "5-methoxy-N,N-dimethyl" or "a pharmaceutically acceptable salt thereof" to "5-methoxy-N,N-dimethyl Treatment of patients with liptamine (5MeO-DMT) or a pharmaceutically acceptable salt thereof By replacing it with "method of placement", it further encompasses all treatment methods defined. It is recognized.

[0096] A clinical response occurs a) within a specific time period, b) lasts at least until a specific time period. or c) "After the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof" Embodiments and claims that are described as existing at a specific point in time are subject to the terms of other embodiments and claims. Through the substance, for example a) “last dose” is actually 5-MeO-DMT or pharmaceutical a) the first dose of the salt that is permissible for the patient, and b) the “last dose” is actually the patient Experience the ultimate psychedelic experience with 5-MeO-DMT or its pharmaceutically acceptable salt. The administration is the first dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. However, a higher dose than the first dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof may be used. This may also be a subsequent administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. It is emphasized that the embodiments and claims include the following.

[0097] Embodiments relating to the treatment of major depressive disorder 1. Diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5) for use in the treatment of patients -MeO-DMT) or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. The use of Embodiment 1 or 2 in a person suffering from moderate or severe major depressive disorder as indicated below. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. For use in the person suffering from severe major depressive disorder as shown in Embodiment 3, 5-MeO- DMT or a pharmaceutically acceptable salt thereof. 5. When the patient is diagnosed with treatment-resistant major depressive disorder, the use described in Embodiments 1-4 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that induces the patient to experience a peak psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 8 Salt. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use described in Embodiments 1 to 22 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Determined by a MADRS score of 24.10 or less or a HAM-D score of 7 or less. Remission of depressive symptoms with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-23 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. 25. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable duration of the salt persists for at least 6 days after the last dose, as described in Embodiments 1-24. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 26. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-25. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose The condition is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM for use in embodiments 1-26 in a state of remission of depressive symptoms T or a pharmaceutically acceptable salt thereof. 28. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 14 days after the last dose, as in Embodiments 1-27. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-28, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to Embodiments 1-29 in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. 31. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... In embodiments 1-30, the allowable salt persists for at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 32. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-31, present on the 28th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to Embodiments 1-32, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will be less likely. This is determined by achieving a total score on the 75 Supreme Psychedelic Experience Questionnaires (PPEQ). Furthermore, the interval between the two administrations during the first treatment block is approximately 1 hour or more and approximately 24 hours or less. And, a second and any subsequent treatment block is administered during the first treatment block, 5- A single dose comprising the maximum dose of MeO-DMT or a pharmaceutically acceptable salt thereof, followed by Embodiment 1: The treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~33.

[0098] Embodiments relating to the treatment of persistent depressive disorder 1. In accordance with accepted medical practices, a qualified professional will diagnose persistent depressive disorder. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of diagnoses (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT 5-MeO-DMT or pharmaceuticals are administered intravenously, intramuscularly, or subcutaneously. The salt that is permissible. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. For use according to Embodiment 1 or 2, for persons suffering from moderate or severe depression as indicated. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. For use in the person suffering from severe depression as shown in Embodiment 3, 5-MeO-DMT or its pharmaceutically acceptable salt. 5. Use according to Embodiments 1-4 in which the patient is diagnosed with treatment-resistant persistent depressive disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9. Administered in a dose or dosage regimen that induces the patient to experience a peak psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 8 Salt. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use described in Embodiments 1 to 22 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Determined by a MADRS score of 24.10 or less or a HAM-D score of 7 or less. Remission of depressive symptoms with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-23 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. 25. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable duration of the salt persists for at least 6 days after the last dose, as described in Embodiments 1-24. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 26. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-25. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose The condition is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-DM for use in embodiments 1-26 in a state of remission of depressive symptoms T or a pharmaceutically acceptable salt thereof. 28. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... As described in Embodiment 27, the allowable salt persists for at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-28, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to Embodiments 1-29 in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. 31. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... In embodiments 1-30, the allowable salt persists for at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 32. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. A clinical response, judged by at least 75% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-31, present on the 28th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the result is determined by a MADRS score of 10 or less or a HAM-D score of 7 or less. 5-MeO-D for use according to Embodiments 1-32, in a state of remission of depressive symptoms MT or its pharmaceutically acceptable salt. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0099] Implementations for the Treatment of Anxiety Disorders 1. Patients diagnosed with anxiety disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5-Me) for use in the treatment of patients O-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is administered intravenously. 5-MeO-DMT or pharmaceutically acceptable drugs are administered via intramuscular or subcutaneous routes. That salt. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a Beck Anxiety Scale (BAI) score of 19 or higher or a Hamilton Anxiety Scale score of 15 or higher. Embodiment 1: A person suffering from moderate or severe anxiety as indicated by the HAM-A anxiety scale score. Alternatively, 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in 2. 4. The patient is indicated by a BAI score of 30 or higher, or a HAM-A score of 24 or higher. For those suffering from severe anxiety, 5-MeO-DMT or drug for use as described in Embodiment 3 That salt is scientifically acceptable. 5. Patient diagnosed with treatment-resistant anxiety disorder, 5 for use according to Embodiments 1-4 -MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The use described in Embodiments 1-22 occurs within approximately 2 hours after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. Determined by a BAI score of 24.9 or less, or by a HAM-A score of 7 or less. Remission of anxiety symptoms is achieved with the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DM for use as described in Embodiments 1 to 23 occurs within approximately 2 hours after administration. T or a pharmaceutically acceptable salt thereof. 25. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt described in Embodiments 1 to 24 persist until at least 6 days after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 26. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable The salt present on the 7th day after the last dose is used for the purposes described in Embodiments 1-25. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose Anxiety disorders in the eyes, as determined by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT or for use according to Embodiments 1-26 in a state of remission of the condition That salt is pharmaceutically acceptable. 28. Compared to the respective scores before treatment, the BAI or HAM-A score was lower. A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt persist until at least 14 days after the last dose, as described in Embodiments 1-27. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 29. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable For the use described in Embodiments 1-28, the salt present on the 14th day after the last dose is used. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], anxiety is assessed by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT for use according to Embodiments 1-29, in a state of symptom remission This is the pharmaceutically acceptable salt. 31. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 50% improvement, is considered acceptable with 5-MeO-DMT or pharmaceutically acceptable. The effects of the salt lasting for at least 28 days after the last dose, as described in Embodiments 1-30. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 32. Compared to the respective scores before treatment, the BAI or HAM-A score is less than A clinical response, judged by a 75% improvement, is met by 5-MeO-DMT or pharmaceutically acceptable For the use described in Embodiments 1-31, the salt present 28 days after the last dose is used. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], anxiety is assessed by a BAI score of 9 or less or a HAM-A score of 7 or less. 5-MeO-DMT for use according to Embodiments 1-32 in a state of symptom remission This is the pharmaceutically acceptable salt. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0100] Embodiments relating to the treatment of post-traumatic stress disorder 1. In accordance with accepted medical practices, post-traumatic stress disorder is diagnosed by a qualified professional. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of diagnoses (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT 5-MeO-DMT or pharmaceuticals are administered intravenously, intramuscularly, or subcutaneously. The salt that is permissible. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient took the Post-Traumatic Stress Disorder Clinical Diagnostic Interview Scale (CAPS-5) for DSM-5. The severity of the condition is indicated by a total score of 23 or more out of 20 severity items, resulting in moderate, severe, or extreme symptoms. 5-MeO-DMT for use in patients suffering from post-traumatic stress disorder, as described in Embodiment 1 or 2. Or a pharmaceutically acceptable salt thereof. 4. The patient's severity is indicated by a total score of 35 or higher across the 20 severity items of the CAPS-5. 5-MeO for use in patients suffering from severe or extreme post-traumatic stress disorder as described in Embodiment 3 - DMT or a pharmaceutically acceptable salt thereof. 5. Use of the embodiments described in Embodiments 1-4 in a patient diagnosed with treatment-resistant post-traumatic stress disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 is lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... Use according to embodiments 1-22, which occurs within approximately 7 days after the last dose of the salt. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 24. The severity is determined by a total score of 10 or less on the 20 severity items of CAPS-5. Remission of symptoms of post-traumatic stress disorder is achieved with 5-MeO-DMT or pharmaceutically acceptable drugs. 5 for use as described in Embodiments 1-23, which occurs within approximately 7 days after the last dose of the salt. -MeO-DMT or a pharmaceutically acceptable salt thereof. 25. Compared to the pre-treatment score, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 14 days after the last dose, as in Embodiments 1-24. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 26. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The salt present on the 7th day after the last dose of the acceptable salt, as described in Embodiments 1-25. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose The severity of the eye is determined by a total score of 10 or less on the CAPS-5 severity scale, which comprises 20 severity items. For use in embodiments 1 to 26, in a state of remission of symptoms of post-traumatic stress disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 28. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 is lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... The acceptable salt persists for at least 21 days after the last dose, as in Embodiments 1-27. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 29. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-28, present on the 14th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the severity is determined by a total score of 10 or less on the CAPS-5 scale, which comprises 20 severity items. For those in a state of remission of post-traumatic stress disorder symptoms, the use described in Embodiments 1 to 29 is appropriate. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31. Compared to the score before treatment, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 30% improvement, is determined by 5-MeO-DMT or pharmaceutically... In embodiments 1-30, the allowable salt persists for at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 32. Compared to the pre-treatment score, the total score of the 20 severity items of CAPS-5 was lower. A clinical response, judged by at least a 50% improvement, is determined by 5-MeO-DMT or pharmaceutically... The use of the salt described in Embodiments 1-31, present on the 28th day after the last dose of the salt, is acceptable. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], the severity is determined by a total score of 10 or less on the CAPS-5 scale, which comprises 20 severity items. For use in a state of remission of symptoms of post-traumatic stress disorder, as described in Embodiments 1 to 32 5-MeO-DMT or a pharmaceutically acceptable salt thereof. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will be less likely. This is determined by achieving a total score on the 75 Supreme Psychedelic Experience Questionnaires (PPEQ). Furthermore, the interval between the two administrations during the first treatment block is approximately 1 hour or more and approximately 24 hours or less. And, a second and any subsequent treatment block is administered during the first treatment block, 5- A single dose comprising the maximum dose of MeO-DMT or a pharmaceutically acceptable salt thereof, followed by Embodiment 1: The treatment block is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in ~33.

[0101] Embodiments relating to the treatment of body dysmorphic disorder 1. Diagnosed with body dysmorphic disorder by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-) for use in the treatment of patients MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is venous 5-MeO-DMT or pharmaceutically acceptable drugs are administered via internal, intramuscular, or subcutaneous routes. The salt that is used. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. Patients with body dysmorphic disorder completed the modified Yale-Brown University Obsessive-Compulsive Disorder Rating Scale. Moderate or severe body dysmorphic disorder as indicated by a score of 31 or higher on the (BDD-YBOCS) scale. For use in the embodiment 1 or 2, 5-MeO-DMT or pharmaceutical The salt that is permissible. 4. The patient has severe body dysmorphic disorder, as indicated by a BDD-YBOCS score of 41 or higher. For those suffering from the condition, 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3 That salt. 5. For use as described in Embodiments 1-4, when the patient is diagnosed with treatment-resistant body dysmorphic disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score indicates The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DM for use as described in Embodiments 1-22 occurs within approximately 7 days after administration. T or a pharmaceutically acceptable salt thereof. 24. Symptoms of body dysmorphic disorder as determined by a BDD-YBOCS score of 16 or less. Remission occurs within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically for use as described in Embodiments 1 to 23 occurs in 5-MeO-DMT or pharmaceutically The salt is acceptable. 25. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to embodiments 1-24, which lasts for at least 14 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 26. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-25 is present on day 7 after administration. or its pharmaceutically acceptable salt. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose The eyes show symptoms of body dysmorphic disorder, as determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or pharmaceuticals for use in the embodiments described in Embodiments 1-26, in a state of remission That salt is generally acceptable. 28. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score is achieved. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to embodiments 1-27, which lasts for at least 21 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 29. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-28, present on day 14 after administration. Or a pharmaceutically acceptable salt thereof. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], symptoms of body dysmorphic disorder are determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or drug for use according to Embodiments 1-29 in a state of remission That salt is scientifically acceptable. 31. An improvement of at least 30% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-M for use according to embodiments 1-30, which lasts for at least 28 days after administration. eO-DMT or a pharmaceutically acceptable salt thereof. 32. An improvement of at least 50% in the BDD-YBOCS score compared to the pre-treatment score is indicated. The clinical response determined by this is the last of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-31, present on day 28 after administration. Or a pharmaceutically acceptable salt thereof. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], symptoms of body dysmorphic disorder are determined by a BDD-YBOCS score of 16 or less. 5-MeO-DMT or drug for use according to Embodiments 1-32 in a state of remission That salt is scientifically acceptable. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0102] Embodiments relating to the treatment of obsessive-compulsive disorder 1. Diagnosed with obsessive-compulsive disorder by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine (5-M) for use in patient treatment eO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is administered intravenously , administered via intramuscular or subcutaneous route, 5-MeO-DMT or pharmaceutically acceptable That salt. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 26 or higher on the Yale-Brown University Obsessive-Compulsive Disorder Rating Scale (Y-BOCS). The patient suffers from moderate or severe obsessive-compulsive disorder as indicated by the core, as described in Embodiment 1 or 2. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 4. The patient suffers from severe obsessive-compulsive disorder, as indicated by a total score of 35 or higher on the Y-BOCS scale. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Embodiment 3. . 5. For use according to Embodiments 1-4, when the patient is diagnosed with treatment-resistant obsessive-compulsive disorder. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 7 mg to 9 mg, or 5-MeO- In embodiments 1 to 12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 23. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is approximately [number missing] after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or for use as described in Embodiments 1-22, which occurs within 7 days That salt is pharmaceutically acceptable. 24. Remission of obsessive-compulsive disorder symptoms, as determined by a YBOCS score of 12 or less, is 5 - Occurs within approximately 7 days after the last dose of MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 23 That salt. 25. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-24, which lasts for at least 14 days. MT or its pharmaceutically acceptable salt. 26. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. A clinical response is observed 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals present on day 1 for use as described in Embodiments 1-25 That salt is generally acceptable. 27. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose In the eyes, remission of obsessive-compulsive disorder symptoms, as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 26 That salt. 28. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-27, which lasts for at least 21 days. MT or its pharmaceutically acceptable salt. 29. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. The clinical response observed is 1 dose after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 4, 5-MeO-DMT or drug for use as described in Embodiments 1-28 is present. That salt is scientifically acceptable. 30. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of obsessive-compulsive disorder symptoms as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 29 The salt that is used. 31. Determined by an improvement of at least 35% in the YBOCS score compared to the score before treatment. The clinical response observed is less severe after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-D for use as described in Embodiments 1-30, which lasts for at least 28 days. MT or its pharmaceutically acceptable salt. 32. Determined by an improvement of at least 50% in the YBOCS score compared to the score before treatment. The clinical response observed is 2 minutes after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or drug for use as described in Embodiments 1-31, present on day 8. That salt is scientifically acceptable. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of obsessive-compulsive disorder symptoms as determined by a YBOCS score of 12 or less. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 32 The salt that is used. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0103] Embodiments relating to the treatment of anorexia nervosa 1. Diagnosed with anorexia nervosa by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of patients ( 5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is 5-MeO-DMT or pharmaceutically administered via intravenous, intramuscular, or subcutaneous route. The salt is acceptable. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient weighed 17 kg / m². 2 Moderate, severe, or extreme body mass index (BMI) is indicated by a BMI of less than a certain value. 5-MeO-D for use in the embodiment 1 or 2 for patients suffering from severe anorexia nervosa MT or its pharmaceutically acceptable salt. 4. The patient weighs 16 kg / m². 2 Severe or extreme nervous appetite, indicated by a body mass index of less than a certain percentage. For use in patients suffering from anorexia, 5-MeO-DMT or pharmaceutically acceptable as described in Embodiment 3. The salt that is used. 5. The use of the embodiments described in Embodiments 1-4 in which the patient is diagnosed with treatment-resistant anorexia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Unless the individual experiences a supreme psychedelic experience, a higher dose than the previous one will be used. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-10. . 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 17 mg to approximately 9 mg, or 5-MeO -In embodiments 1-12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the body mass index before administration of 23.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable Use according to Embodiments 1-22 occurs within approximately 28 days after the last dose of the salt to be tolerated. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 24. At least 18.5 kg / m 2 Anorexia nervosa, as determined by the body mass index. Remission occurred approximately 56 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-23, occurring within 24 hours That salt is generally acceptable. Compared to the body mass index before administration of 25.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable The effects of the salt being tolerated persist for at least 56 days after the last dose, as described in Embodiments 1-24. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the body mass index before administration of 26.5-MeO-DMT, the body mass index was at least 1 kg / m 2 The clinical response, as determined by an increase in 5-MeO-DMT or pharmaceutically acceptable The salt present on the 28th day after the last dose is used according to Embodiments 1-25. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 27. The patient has 56 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, at least 18.5 kg / m 2 Anorexia nervosa, determined by the body mass index. 5-MeO-DMT or for use according to Embodiments 1-26 in a state of remission of the disease That salt is pharmaceutically acceptable. For use as described in Embodiments 1 to 27, administered in 28.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 29. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 28 salt. 30. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 28-29, including administration of the salt This is the pharmaceutically acceptable salt. 31. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 28-30. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 32. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 28-31, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 33. The second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 28 or 32, including the Pharmacopoeia That salt is generally acceptable. 34,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatments described in Embodiments 1 to 27 are administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 35,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-27 .

[0104] Embodiments relating to the treatment of bulimia nervosa 1. Diagnosed with bulimia nervosa by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-) for use in the treatment of patients MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is venous 5-MeO-DMT or pharmaceutically acceptable drugs are administered via internal, intramuscular, or subcutaneous routes. The salt that is used. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient exhibits moderate or severe bulimia nervosa, characterized by four or more episodes of binge eating and vomiting per week. For use in individuals suffering from bulimia nervosa, 5-MeO-DMT for use as described in Embodiment 1 or 2. Or a pharmaceutically acceptable salt thereof. 4. Severe bulimia nervosa, characterized by 8 or more episodes of binge eating and vomiting per week. For those suffering from the disease, 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3. That salt. 5. For use as described in Embodiments 1-4, when the patient is diagnosed with treatment-resistant bulimia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 17 mg to approximately 9 mg, or 5-MeO -In embodiments 1-12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of binge eating and vomiting episodes per week prior to administration of 23.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response occurred within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically for use as described in Embodiments 1 to 22 occurs in 5-MeO-DMT or pharmaceutically The salt is acceptable. Symptoms of bulimia nervosa are determined by 0 episodes of binge eating and vomiting per week. Remission occurs approximately 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically active ingredients generated within the use described in Embodiments 1 to 23 The salt that is permissible. Compared to the number of binge eating and vomiting episodes per week prior to administration of 25.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-24, which lasts for up to 14 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 26.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response is present on day 7 after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 25. The salt that is used. 27. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-26 in a state of remission That salt is scientifically acceptable. Compared to the number of binge eating and vomiting episodes per week prior to administration of 28.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-27, which lasts for up to 21 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 29.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response occurred 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Existing 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 28 The salt is tolerable. 30. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-29 in a state of remission That salt is scientifically acceptable. Compared to the number of binge eating and vomiting episodes per week prior to administration of 31.5-MeO-DMT, Clinical assessment is made by a reduction of at least 50% in the number of binge eating and purging episodes per week. The response was at least the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT for use as described in Embodiments 1-30, which lasts for up to 28 days. This is the pharmaceutically acceptable salt. Compared to the number of binge eating and vomiting episodes per week prior to administration of 32.5-MeO-DMT, Clinical assessment is made by a reduction of at least 75% in the number of binge eating and purging episodes per week. The response occurred 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Existing 5-MeO-DMT or pharmaceutically acceptable 5-MeO-DMT for use as described in Embodiments 1 to 31 The salt is tolerable. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Symptoms of bulimia nervosa are determined by zero episodes of binge eating and vomiting per week. 5-MeO-DMT or drug for use according to Embodiments 1-32 in a state of remission That salt is scientifically acceptable. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0105] Embodiments relating to the treatment of bulimia nervosa 1. Diagnosed with bulimia nervosa by a qualified professional in accordance with accepted medical procedures. 5-methoxy-N,N-dimethyltryptamine (5-M) for use in patient treatment eO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is administered intravenously , administered via intramuscular or subcutaneous route, 5-MeO-DMT or pharmaceutically acceptable That salt. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has moderate or severe episodes of overeating, as indicated by four or more episodes per week. For use in individuals suffering from bulimia, 5-MeO-DMT or as described in Embodiment 1 or 2 That salt is pharmaceutically acceptable. 4. The patient suffers from a severe bulimia disorder characterized by eight or more episodes of binge eating per week. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 3 salt. 5. For use according to Embodiments 1-4, when the patient is diagnosed with treatment-resistant bulimia nervosa. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Unless the individual experiences a supreme psychedelic experience, a higher dose than the previous one will be used. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-10. . 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 17 mg to approximately 9 mg, or 5-MeO -In embodiments 1-12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. The first dose of 14.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 13. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of binge eating episodes per week before administration of 23.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, Occurs within approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 22 That salt. 24. Remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. Within approximately 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 23. The salt that is used. Compared to the number of binge eating episodes per week before administration of 25.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-24, which lasts until The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 26.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, 5-MeO-DMT or a pharmaceutically acceptable salt thereof is present 7 days after the last dose. 5-MeO-DMT or pharmaceutically acceptable so for use as described in Embodiments 1 to 25 Salt. 27. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-26 The salt is acceptable. Compared to the number of binge eating episodes per week before administration of 28.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 21 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-27, which lasts until [time]. The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 29.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, It is present 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 28 That salt. 30. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-29 The salt is acceptable. Compared to the number of binge eating episodes per week before administration of 31.5-MeO-DMT, A clinical response, as determined by a reduction of at least 50% in the number of overeating episodes per interval, At least 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically effective for use as described in Embodiments 1-30, which lasts until The salt that is permissible. Compared to the number of binge eating episodes per week before administration of 32.5-MeO-DMT, A clinical response, as determined by a reduction of at least 75% in the number of overeating episodes per interval, It is present 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 31 That salt. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], remission of symptoms of bulimia nervosa, as determined by 0 binge eating episodes per week. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-32 The salt is acceptable. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0106] Embodiments relating to the treatment of psychoactive substance abuse 1. Diagnosis of psychoactive substance abuse by a qualified professional in accordance with accepted medical practices. 5-methoxy-N,N-dimethyltryptamine for use in the treatment of patients ( 5-MeO-DMT) or a pharmaceutically acceptable salt thereof, wherein 5-MeO-DMT is 5-MeO-DMT or pharmaceutically administered via intravenous, intramuscular, or subcutaneous route. The salt is acceptable. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has at least four of the 11 DSM-5 diagnostic criteria for substance use disorder. The existence of criteria indicates that the person is suffering from moderate or severe psychoactive substance abuse. 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Form 1 or 2 salt. 4. The patient has met at least six of the 11 DSM-5 diagnostic criteria for substance use disorder. The existence of a discriminatory standard indicates that the person suffers from severe psychoactive substance abuse, as described in Embodiment 3. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 5. The use described in Embodiments 1-4 in which the patient is diagnosed with treatment-resistant psychoactive substance abuse. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 6. If the patient further suffers from suicidal ideation, 5-MeO-D for use as described in Embodiments 1-5. MT or its pharmaceutically acceptable salt. 7. 5-M for use as described in Embodiment 6, for patients suffering from suicidal ideation accompanied by the intention to carry it out. eO-DMT or a pharmaceutically acceptable salt thereof. 8. 5-M for use as described in Embodiments 1-7 when the patient is at imminent risk of suicide. eO-DMT or a pharmaceutically acceptable salt thereof. 9,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-8, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 10. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 11. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-M Embodiments 1-9 in which equimolar amounts of pharmaceutically acceptable salt are administered instead of eO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 12,5-MeO-DMT or a salt thereof is administered in the first dose, and 5 -MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Use a higher dose than the previous one unless the person experiences a supreme psychedelic experience. , 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiments 1 to 10 That salt. 13.5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 17 mg to approximately 9 mg, or 5-MeO -In embodiments 1-12, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. The first dose of 14.5-MeO-DMT is approximately 2, and the second dose of 5-MeO-DMT is The amount is approximately 5 mg, and the third dose of 5-MeO-DMT is approximately 8 mg, or 5- Embodiment 13: Instead of MeO-DMT, an equimolar amount of a pharmaceutically acceptable salt is administered. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described above. 15. The interval between 15.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. For use as described in Forms 12-14, use 5-MeO-DMT or pharmaceutically acceptable so Salt. 16. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 9-15, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 17. The occurrence of a supreme psychedelic experience is at least 75 supreme psychedelic experience questions. The use described in Embodiment 16 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 19. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-18, occurring within 18 That salt is generally acceptable. 20. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 19, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 21. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-20, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 22. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-21, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. Compared to the number of 23.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response occurs approximately 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1 to 22, occurring within 20 days That salt is generally acceptable. 24. Of the 11 DSM-5 diagnostic criteria for substance use disorder, zero criteria exist. Remission of psychoactive substance abuse, as determined by 5-MeO-DMT or pharmacy The use described in Embodiments 1-23 occurs within approximately 14 days after the last dose of the salt that is permissible. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 25.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-24, which lasts for up to 14 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 26.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed 7 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically available for use as described in Embodiments 1-25 The salt is acceptable. 27. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 26 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 28.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-27, which lasts for up to 21 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 29.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response within 14 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable substances present in the eye for use as described in Embodiments 1-28 The salt that is permissible. 30. The patient has 21 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 29 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. Compared to the number of 31.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 50% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response is observed with less than one dose of 5-MeO-DMT or its pharmaceutically acceptable salt. 5-MeO-DMT for use as described in Embodiments 1-30, which lasts for up to 28 days. Or a pharmaceutically acceptable salt thereof. Compared to the number of 32.5-MeO-DMT doses before administration, 11 DSMs for substance use disorders - Determined by a reduction of at least 75% of the number of existing diagnostic criteria out of the 5 diagnostic criteria. Clinical response within 28 days after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceutically acceptable substances present in the eye for use as described in Embodiments 1-31 The salt that is permissible. 33. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day [number], there were 0 of the 11 DSM-5 diagnostic criteria for substance use disorder. The states described in Embodiments 1 to 32 are in a state of remission from psychoactive substance abuse, as determined by the following: 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. For use as described in Embodiments 1 to 33, administered in 34.1 or multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 35. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 34 salt. 36. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 34-35, including administration of the salt This is the pharmaceutically acceptable salt. 37. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 34-36. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 38. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 34-37, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 39. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 34 or 38, including the Pharmacopoeia That salt is generally acceptable. 40,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 33 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 41,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-33 .

[0107] Treatment of major depressive disorder with suicidal ideation or imminent risk of suicide Embodiments relating to placement 1. Diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practices. Furthermore, it is diagnosed by a qualified professional in accordance with accepted medical practices, with consent. For use in the treatment of patients who have suicidal ideation or are at imminent risk of suicide. 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or pharmaceutical The salt of which is permissible, and in which 5-MeO-DMT is administered intravenously, intramuscularly or subcutaneously. The administered salt is 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 2. The disorder is described in the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM), published by the American Psychiatric Association. 5-MeO-DMT or drug for use as described in Embodiment 1, diagnosed according to -5) That salt is scientifically acceptable. 3. The patient has a score of 20 or higher on the Montgomery-Asberg Depression Rating Scale (MADRS). By, or by the Hamilton Depression Rating Scale (HAM-D) score of 17 or more items. Patients suffering from moderate or severe major depressive disorder, and with a clinically balanced overall impression of suicidal tendencies. Based on the Critical Severity-Revised (CGI-SS-R) scale, moderate suicidal tendency, marked suicidal tendency, severe Suicidal tendencies, or what is considered to be extreme suicidal tendencies, are the use of the method described in Embodiment 1 or 2. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 4. The patient is diagnosed with a MADRS score of 35 or higher, or a HAM-D score of 25 or higher. Patients suffering from severe major depressive disorder, and also with a revised clinical overall impression score - suicidal tendency severity score ( Based on the CGI-SS-R scale, marked suicidal tendency, severe suicidal tendency, or extreme suicidal inclination 5-MeO-DMT or pharmaceutically acceptable for use as described in Embodiment 3 is considered appropriate. The salt is tolerable. 5. When the patient is diagnosed with treatment-resistant major depressive disorder, the use described in Embodiments 1-4 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 6,5-MeO-DMT or its salts are used to induce a supreme psychedelic experience in patients. 5-MeO for use as described in Embodiments 1-5, administered in a quantity or dosage regimen. - DMT or a pharmaceutically acceptable salt thereof. 7. A dose of approximately 1 mg to 10 mg of 5-MeO-DMT is administered, or 5-MeO-DMT In embodiments 1-6, an equimolar amount of a pharmaceutically acceptable salt is administered instead of O-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 8. A dose of approximately 2 mg, 5 mg, or 8 mg is administered, or 5-Me In embodiments 1-6, an equimolar amount of a pharmaceutically acceptable salt is administered instead of O-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for the use described. 9,5-MeO-DMT or its salt is administered in the first dose for the first administration, and 5- MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses, with each subsequent dose being administered to the patient. Unless they experience a supreme psychedelic experience, use a higher dose than the previous one. 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiments 1 to 7 salt. 10,5-MeO-DMT is administered in a dose of approximately 1 mg to 3 mg for the first dose. Subsequently, unless the patient has already experienced a peak psychedelic experience, the second dose should be approximately 4 mg. The dosage was increased to approximately 6 mg, after which the patient had already experienced a supreme psychedelic experience. Unless otherwise specified, the third dose will be increased to approximately 17 mg to approximately 9 mg, or 5-MeO -In embodiments 1 to 9, an equimolar amount of a pharmaceutically acceptable salt is administered instead of DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. The first dose of 11.5-MeO-DMT is approximately 2 mg, and the second dose of 5-MeO-DMT is approximately 2 mg. The dosage of the first drug is approximately 5 mg, and the third dosage of 5-MeO-DMT is approximately 8 mg. In practice, equimolar amounts of a pharmaceutically acceptable salt are administered instead of 5-MeO-DMT. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use as described in Form 10. 12. The interval between 12.2 doses is between 1 hour and 24 hours, for example, approximately 2 to 4 hours. 5-MeO-DMT or pharmaceutically acceptable substance for use as described in application forms 9-11 salt. 13. The occurrence of a supreme psychedelic experience is related to the 30-item revised Mystical Experience Questionnaire (MEQ30) ) of the four subscales (mystical, positive mood, transcendence of space and time, and inexpressibility) This is identified by achieving at least 60% of the highest possible score in each, or At least 6 of the highest possible scores on the Observational Nervous System (OBN) section of the Altered States of Consciousness (ASC) questionnaire. Identified by achieving 0% or at least 75 Supreme Psychedelic Experience Questions The use described in Embodiments 6 to 12, as identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 14. The occurrence of a supreme psychedelic experience is based on at least 75 supreme psychedelic experience questions. The use described in Embodiment 13 is identified by achieving the total score of the votes (PPEQ). 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 15. 5 for use as described in any of the preceding embodiments, administered by intramuscular injection. -MeO-DMT or a pharmaceutically acceptable salt thereof. 16. Clinical Global Impression-Improvement (CGI-I) score or patient-reported global impression-improvement. Clinical assessment is determined by a score of at least "marked improvement" in the PGI-I score. The bed response occurred approximately 2 hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 5-MeO-DMT or pharmaceuticals for use as described in Embodiments 1-15, occurring within 15 That salt is generally acceptable. 17. At least a “marked improvement” in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use according to embodiments 1 to 16, which lasts until at least 6 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 18. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-17, the effects last until at least 14 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 19. A score of at least "marked improvement" in the CGI-I score or PGI-I score. The clinical response determined by A is 5-MeO-DMT or its pharmaceutically acceptable salt. For use as described in Embodiments 1-18, the effects last until at least 28 days after the last dose. 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 20. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use as described in Embodiments 1-19 occurs within approximately 2 hours thereafter. Or a pharmaceutically acceptable salt thereof. A MADRS score of 21.10 or lower, or a HAM-D score of 7 or lower, and CGI-S This is determined by the score on the SR scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. Remission of depressive symptoms and suicidal ideation with 5-MeO-DMT or pharmaceutically acceptable 5- for use as described in Embodiments 1-20, occurring within approximately 2 hours after the last dose of salt MeO-DMT or a pharmaceutically acceptable salt thereof. 22. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO- for use according to Embodiments 1-21, which lasts for at least 6 days thereafter. DMT or a pharmaceutically acceptable salt thereof. 23. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT or for use as described in Embodiments 1-22, present on the 7th day after the first use. That salt is pharmaceutically acceptable. 24. If the patient has had 5-MeO-DMT or a pharmaceutically acceptable salt thereof for 7 days since the last dose In the eyes, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI-S This is determined by the score on the SR scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. 5 for use according to Embodiments 1-23, in a state of remission of depressive symptoms and suicidal ideation -MeO-DMT or a pharmaceutically acceptable salt thereof. 25. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO for use according to Embodiments 1-24, which lasts for at least 14 days after the use described above. - DMT or a pharmaceutically acceptable salt thereof. 26. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use described in Embodiments 1-25, which is present on the 14th day after the initial exposure. This is the pharmaceutically acceptable salt. 27. The patient has 14 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI- The determination is made based on the SS-R scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. For use in embodiments 1 to 26, in a state of remission of depressive symptoms and suicidal ideation 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 28. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by a 50% improvement and at least one level reduction on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO for use according to Embodiments 1-27, which lasts for at least 28 days after the use described above. - DMT or a pharmaceutically acceptable salt thereof. 29. Compared to the respective scores before treatment, the MADRS or HAM-D score was lower. This can be determined by an improvement of at least 75% and a reduction of at least two levels on the CGI-SS-R scale. The clinical response determined by the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof is considered sufficient. 5-MeO-DMT for use described in Embodiments 1-28, which is present on day 28. This is the pharmaceutically acceptable salt. 30. The patient has 28 days since the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof. On day 1, a MADRS score of 10 or less or a HAM-D score of 7 or less, and CGI- The determination is made based on the SS-R scale, which indicates either no suicidal tendencies or suspected suicidal tendencies. For use in embodiments 1 to 29, in a state of remission of depressive symptoms and suicidal ideation 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 31.1 For use as described in Embodiments 1 to 30, administered in multiple treatment blocks 5-MeO-DMT or a pharmaceutically acceptable salt thereof. 32. The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. , 5-MeO-DMT or pharmaceutically acceptable thereof for use as described in Embodiment 31 salt. 33. The first treatment block is 5-MeO-DMT or as defined in Embodiments 9-18 5-MeO-DMT for use according to Embodiments 31-32, including administration of the salt This is the pharmaceutically acceptable salt. 34. The first treatment block includes 1 to 7 doses of the dose at which the patient experienced a peak experience. The interval between each administration is approximately 1 hour or more and approximately 24 hours or less, as described in Embodiments 31-33. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for this purpose. 35. Each treatment block consists of 1 to 7 doses, with approximately 1 hour between each dose within each treatment block. 5-MeO-D for use as described in Embodiments 31-34, which is between 24 hours and approximately 24 hours. MT or its pharmaceutically acceptable salt. 36. A second and any subsequent treatment block is administered during the first treatment block. - MeO-DMT or the maximum dose of its pharmaceutically acceptable salt, one or more doses 5-MeO-DMT or pharmaceuticals for use as described in Embodiment 31 or 35, including the Pharmacopoeia That salt is generally acceptable. 37,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. The four subscales of the 30-item revised Mystical Experiences Questionnaire (MEQ30) (mystical, positive experiences) At least the highest possible score in each of the following (minutes, transcendence of space and time, and inexpressibility) It is also identified by achieving 60% or by the oceanic feeling on the Altered States of Consciousness (ASC) questionnaire. Identified by achieving at least 60% of the highest possible score on the OBN surface, and the first action The interval between the two doses during the block is approximately 1 hour or more and approximately 24 hours or less, and the second and third The subsequent treatment block is administered during the first treatment block, along with 5-MeO-DMT. or a single dose of the maximum pharmaceutically acceptable dose of the salt, followed by a block of subsequent treatments. The treatment described in Embodiments 1 to 30 is administered at least about 6 days after the preceding treatment block. 5-MeO-DMT or a pharmaceutically acceptable salt thereof for use. 38,5-MeO-DMT or a pharmaceutically acceptable salt thereof in two or more treatment blocks Administered, and in the first treatment block, 5-MeO-DMT or a salt thereof is administered in the first dose. Administered in the first dose, 5-MeO-DMT or its salt is 0 in the first treatment block. It is administered in 6 subsequent doses, with each subsequent dose leading to the patient experiencing a supreme psychedelic experience. Unless otherwise specified, a higher dose than the previous administration will be used, and the occurrence of a supreme psychedelic experience will occur. By achieving a total score of at least 75 Supreme Psychedelic Experience Questionnaires (PPEQ) It was identified that the interval between the two doses during the first treatment block was approximately 1 hour or more and approximately 24 hours or less. Below, a second and any subsequent treatment block is administered during the first treatment block. A single dose comprising the maximum dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof, The subsequent treatment block is administered at least approximately 6 days after the preceding treatment block. 5-MeO-DMT or pharmaceutically acceptable salt thereof for use as described in Forms 1-30 . [Examples]

[0108] The following examples are listed to aid in understanding the present invention and the claims that follow. This does not limit the invention as described in the box in any way, and is not construed as limiting it. It shouldn't be done.

[0109] [Example 1] [Example 1A] Administration of 5-MeO-DMT by inhalation Volcano Medic Vaporization System Volcano Medic Vaporization System(Storz By using Bickel (Germany) to volatilize the drug, 5-MeO-DM T aerosol was generated. The device is a hot air generator and the patient receives the aerosol from it. It consists of a detachable valve balloon for suction. The hot air generator is regulated between approximately 40°C and 210°C. The device can generate the desired temperature, and the airflow rate is approximately 12 liters per minute. The central part is a medication cap to which an appropriate dose of 5-MeO-DMT in ethanol solution is applied. The cell, and the capsule, are then applied to the device's filling chamber, where they are heated by hot air. It is heated. The medication capsule is tightly packed with stainless steel wire mesh (drip). It contains a small disc made from a pad (also called a liquid pad). The bottom and lid of the container have holes, which allow airflow to pass through the medication capsule. The medication capsules and drip pads were measured based on the following measurements of 10 sample capsules. It has the following characteristics:

[0110] [Table 1]

[0111] Production and administration of 5-MeO-DMT aerosol Step 1: The target dose of 5-Me is administered to the volunteer or patient by inhalation. In 100% ethanol, such that O-DMT free base is contained in a solution volume of 200 μl. A stock solution of 5-MeO-DMT free base is prepared in a volumetric flask. A typical standard The recommended dosage is 1 mg to 25 mg of 5-MeO-DMT. For example, 18 mg of 5-MeO-DMT. For the target dose of eO-DMT, 90 mg is used in 5 doses so that the final solution volume is 1 ml. -MeO-DMT is dissolved in 100% ethanol. Then, aliquots of the stock solution are prepared. It may be stored in the vial until further use.

[0112] Step 2: Dissolve 200 μl of the solution in a medication capsule containing a drip pad (Storz Transfer to Bickel (Germany) and close the medication capsule with the lid.

[0113] Step 3: Place the medication capsule filled with 5-MeO-DMT ethanol solution into a container at 55°C. The first Volcano Medic Vapor was preheated to the set temperature. Transfer to the izer's filling chamber. Next, set the vaporizer's airflow to a preset speed of approximately 12 l / min. Turn it on at 60 seconds. The heated air flows through the medication capsule, thereby ethanol The ol evaporates, and the target dose of 5-MeO-DMT covers the stainless steel wire mesh. It remains in the capsule as a thin layer. Precise preparation of the medication capsule is done by comparing the weight of the empty capsule with that of the capsule. The final weight increase of the compared capsules was found to be approximately equal to the target dose of 5-MeO-DMT. It can be confirmed by providing proof.

[0114] Step 4: Remove the prepared medication capsule from the filling chamber. Then, the medication capsule The second Volcano Medi cell was preheated to a temperature set at 210°C. Transfer to the Vaporizer filling chamber and turn on the airflow for at least 5 minutes. Turn it off immediately before use. Fill with a valved inhalation balloon (Storz & Bickel, Germany). Attach it to the chamber socket, seal the filling chamber, and immediately afterwards introduce an airflow of approximately 12 l / It turns on for exactly 15 seconds at a pre-set speed of minutes, and then turns off. This allows 5-MeO -The entire dose of DMT is aerosolized and dispersed into approximately 3 liters of air within the inhalation balloon. The precise aerosolization of 5-MeO-DMT results in a capsule weight that is approximately its initial weight. This can be confirmed by demonstrating that the quantity has returned to its original state.

[0115] Step 5: Next, the valve will close automatically when the balloon is removed from the filling chamber. Once the nozzle is attached to the balloon, the aerosol can be immediately administered to the volunteer or patient. It will enter that state.

[0116] Step 6: In preparation for administration, have the patient first take one or two deep breaths and exhale completely, and then... Ask them to exhale deeply to finish. Next, firmly place the nozzle against their lips and inhale the inhalation balloon. Inhale the entire volume completely in one breath, hold your breath for 10 (±2.5) seconds, and exhale naturally. After the inhalation procedure is complete, instruct the patient to lie down.

[0117] [Example 1B] Preparation of starting materials 5-MeO-DMT (2.0g) is converted to MTBE (4mL, 2.0 volts) at 35-40°C. It was dissolved and then cooled to room temperature over 30 minutes. After stirring at room temperature for 50 minutes, crystallization was observed. Since it wasn't available, the batch temperature was lowered to 7-12°C over 30 minutes. Stirring was performed at 7-12°C for 10 minutes. Crystallization occurred upon mixing. Next, the batch was filtered after stirring at 7-12°C for 1 hour. After washing with MTBE (1 mL, 0.5 volume) at 7-12°C, the batch was aspirated under vacuum for 3.5 hours. The sample was dried to obtain 1.02 g of a pale orange solid (recovery rate 50%). The isolated solid was subjected to HPLC. Therefore, the purity was analyzed. The purity was found to be 99.74% by area.

[0118] The table below shows the impurity profiles of the isolated materials.

[0119] [Table 2]

[0120] The analysis results showed an increase in the overall purity of the material, RRT1.18 and RRT1.2 It was shown that impurity 4 was removed to less than 0.10%. The impurity RRT2.38 was also removed. The NMT was reduced to below the target of 0.10%.

[0121] Solvent analysis of the sample revealed an MTB of 17 ppm, compared to the expected limit of NMT 5000 ppm. E level was indicated.

[0122] [Example 2] 5-MeO-DMT administered by inhalation to patients with treatment-resistant major depressive disorder. Clinical trials Research design: A clinical trial was conducted, and 5-MeO- was administered to patients with treatment-resistant major depressive disorder (TRD). Free DMT base (purity 99% or higher) was administered. The purpose of the study was to evaluate 5-MeO-DMT. Daily drug safety and tolerability, dose-related psychedelic effects, and various indicators of depression. The objective was to determine the effect on [the subject]. The trial was conducted by the appropriate national competent authority and local pharmaceutical company. Reviewed and approved by the Product Ethics Committee. Patients recruited for the trial were single-episode patients. Or, Recurrent Major Depressive Disorder, Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM- 5) The diagnostic criteria must be met and the patient must be treatment-resistant, and all aspects must be met by a psychiatrist. This was evaluated by a clinical psychologist. It involved the use of psychoactive drugs or substances (such as antidepressants). Patients who have been taking such medications or substances should discontinue them and take a break before administering 5-MeO-DMT. It was necessary to observe the duration. On the day of administration, a single dose of 12 mg of 5-MeO-DMT was administered. As described in Example 1A, the drug was administered to the patient in a single inhalation. After administration, the patient was kept for 3.5 hours. Careful monitoring will be conducted, with additional follow-up visits scheduled one and seven days after medication administration. Various safety-related indicators (e.g., reporting of adverse events, laboratory safety analysis, vital signs) Signs, electrocardiogram (ECG), clinical diagnostic interview, Dissociative Dissociative Status Scale (CADSS), psychomotor arousal test (PVT, Digital Substitution Test (DSST)), an index of the intensity of the psychedelic effect (example) For example, the Supreme Psychedelic Experience Questionnaire (PPEQ), the Altered States of Consciousness (ASC) Questionnaire, God Confidential Experience Questionnaire (MEQ30), subjective descriptions of psychedelic experiences, severity of depression Indicators (Montgomery-Asberg Depression Rating Scale (MADRS), patient's overall impression - Severity scale (PGI-S), Patient's overall impression-improvement scale (PGI-I), and Further psychological indicators (e.g., Columbia Suicide Severity Rating Scale (C-SSRS), Simplified Psychological Patients recorded their Psychological Symptom Rating Scale (BPRS) scores at different points in time. Throughout the study, patients were also referred by a psychologist. and / or psychological support from a psychiatrist was available, but specific psychotherapies were not suitable. It was not used, and no additional psychoactive drugs were provided.

[0123] Patient characteristics: Two patients diagnosed with major depressive disorder by a psychiatrist according to the DSM-5 diagnostic criteria. Patients were recruited for the study (Example 2, Table 1). Patients were taking medication for their current depressive episode. Because the patient did not show adequate improvement after at least two appropriate sessions of physical therapy, treatment was deemed ineffective. It was considered resistant.

[0124] [Table 3]

[0125] result: The patient completed all scheduled visits. The inhalation procedure was performed correctly by the patient. Furthermore, it was well-tolerated with no inhalation-related adverse events. The first cyanopathic reaction occurred within a few seconds of inhalation. Kederic symptoms occurred. This occurred during the continuation of a psychedelic experience as judged by an external observer. The interval was 16 minutes for patient 1 and 40 minutes for patient 2.

[0126] Temporary, clinically unrelated increases in heart rate and blood pressure immediately after administration of 5-MeO-DMT Aside from the rise in vital parameters, no other significant changes occurred. ECG (3 minutes after administration) (Hour 1), Laboratory analysis of safety (Hour 3 and Day 7), CADSS (Hour 3, Day 1) The results of the eye and day 7 tests, as well as cognitive tests (PVT, DSST, day 1 and day 7), are as follows: The adverse events were not significant. The few reported adverse events were mild and short-lived, and did not occur before the end of the study. It spontaneously disappeared (Example 2, Table 2).

[0127] [Table 4]

[0128] Regarding the intensity of the psychedelic experience, Patient 1 scored supreme based on all three assessment scores. Patient 1 met the criteria for Ikederic experience, while Patient 2 met the criteria for MEQ30 and PPEQ. However, it did not meet the ASC standards (Example 2, Table 3).

[0129] [Table 5]

[0130] Surprisingly, the patient already had MADRS, P at the first assessment two hours after drug administration. We report on the major improvement in those depressive symptoms as assessed by GI-S and PGI-I. The effect deepened further over time (Example 2, Table 4). Patients also experienced all of the following symptoms after drug administration. At the time of assessment, MADRS response (at least 50% improvement from baseline) and MAD Meeting the standard criteria for RS remission (MADRS total score of 10 or less) and in PGI-S They were assessed as "normal, not ill at all," and in the PGI-I, those depressive symptoms were "extremely severe." It was reported that there was a "significant improvement" or "significant improvement," which is an extremely surprising result. be.

[0131] Patients are assessed using the suicidal ideation items of the MADRS and the suicidal ideation items of the C-SSRS. Improvement was also observed in those assessments regarding suicidal tendencies after drug administration. Other common psychiatric symptoms that may be determined by this assessment include hypochondria, anxiety, guilt, and tension. It also improved after drug administration.

[0132] Importantly, Patient 1 and Patient 2 showed similar intensities of psychedelic effects, This correlated with similar antidepressant clinical responses. This observation suggests that the occurrence of peak experiences is associated with 5-MeO2. -A surrogate behavior of a key mechanism, or at least an underlying mechanism, of the therapeutic efficacy of DMT. It is supported that it is a marker.

[0133] [Table 6]

[0134] Summary and conclusion: A. A single dose of 12 mg of 5-MeO-DMT administered by inhalation was well-tolerated. And in patients formally diagnosed with treatment-resistant major depressive disorder, there was a remarkably significant clinical finding. It induces a bed response. Such a remarkable clinical response in treatment-resistant patients has previously been It is highly likely that clinical responses will occur even in patients undergoing treatment. B. Clinical responses occur rapidly within 2 hours after administration of 5-MeO-DMT. Rapid onset is rare, and tricyclic antidepressants generally take 4-6 weeks to show their effects. Drugs, monoamine oxidase inhibitors, selective serotonin reuptake inhibitors (SSRIs), sero Conventional class of antiparasitic agents, including tonin-norepinephrine reuptake inhibitors (SNRIs) This has not been observed with other medications. C. The patient experienced clinical remission within 2 hours after a single dose of 5-MeO-DMT. This is in addition to other treatments approved for major depressive disorder, and all previously tested therapies. It is far superior to Kederick's drugs. D. Clinical response was observed when 5-MeO-DMT was administered only once, and within this time frame the body no longer... Despite not being effectively present, the condition deepened further over the 7-day follow-up period. (See the pharmacokinetic data in Example 3 below.) This observation indicates that 5-MeO-D The superior clinical profile of MT supports the possibility of convenient dosing intervals. Traditional antidepressants were oral medications intended for daily administration over long periods. E. In addition to antidepressant effects, the endpoint for assessing suicidal ideation was also positively affected. Patients at imminent risk of suicide, such as those with active suicidal ideation accompanied by an intention to commit suicide. The use of 5-MeO-DMT in patients with suicidal ideation is supported. F. In addition to antidepressant effects, it also helps with other psychiatric symptoms (hypochondria, anxiety, guilt, and tension). The endpoints being assessed were also positively affected, and in patients with other mental disorders, 5- The use of MeO-DMT is supported. The intensity of acute psychedelic effects after G.5-MeO-DMT administration and the long-term resistance to acute effects. A correlation was observed between the effects of the treatments. This suggests that the peak experience was more rapidly achieved in patients with greater The advantages of achieving this proportionally and improving reproducibility in individual patients make treatment profiles It has been demonstrated that the effects improve. A supreme psychedelic experience is observed in some patients with low doses of 5 - This can already occur with MeO-DMT (6 mg, see Example 3 below), but other The observation is that some patients require high doses (e.g., 18 mg; see Example 3 below). Therefore, the therapeutic efficacy of a wide range of 5-MeO-DMT doses is supported, and 5-MeO-D In patients who did not achieve a peak experience after the first dose of MT, any subsequent doses would not be effective if the patient did not reach a peak experience. A higher dose than the previous one should be used until a high psychedelic experience is achieved. This concept is supported.

[0135] Each of the aforementioned aspects A) to G) is unexpected and highly medically relevant. Aspect A) ~G) 5-MeO-DMT, when used according to the present invention, is used for major depressive disorder. Compared to pharmacologically approved treatments and all previously tested psychedelic agents It shows a significantly improved efficacy profile. Acute psychedelic effect These data, combined with a short duration and a favorable safety profile, suggest that major depression may be a contributing factor. Technical problems in providing improved psychoactive therapy in patients with sexual disorders It is shown that this can be resolved by Akira. Identification of 5-MeO-DMT observed in this study. Based on its effects on psychiatric symptoms, the technical problem is persistent depressive disorder, anxiety disorder Post-traumatic stress disorder, body dysmorphic disorder, obsessive-compulsive disorder, eating disorders and psychoactive substance abuse It is highly likely that this will also be resolved.

[0136] [Example 3] Clinical trial of 5-MeO-DMT administered to healthy volunteers by inhalation. Research design: Clinical trials were conducted to determine different dose levels of 5-MeO-DMT free base (purity 99% or higher). ) Healthy volunteers who have previously used synthetic or naturally occurring psychedelic drugs The drug was administered to the patient by inhalation over one day (as described in Example 1). The study was conducted in the appropriate country. Reviewed and approved by the relevant authorities within the country and the regional pharmaceutical ethics committee. There were two trials. It consisted of the following parts: Part A contained 5-M 2mg, 6mg, 12mg and 18mg A single dose of eO-DMT was administered, and in Part B, 6 mg of 5-MeO-DMT was administered. The initial dose is administered, and then the participant has already experienced a supreme psychedelic experience based on PPEQ. Unless otherwise specified, or if the supervising physician advises against further dose increases based on observed side effects, Unless it is determined to be appropriate, further subsequent doses of 12 mg and 18 mg are not recommended. The doses were administered approximately 3 hours apart. Participants in Part A received only one dose, and Part A Administering higher doses in the second half was not permitted, and participation in Part B was not permitted. Participants were carefully monitored for 3.5 hours after the final dose, and 1 day after administration and An additional follow-up visit was conducted 7 days later. Various safety-related indicators (e.g., adverse events) were examined. Elephant reports, laboratory safety analysis, vital signs, ECG, CADSS, PVT, DSS T, prospective memory task (PMT), and an index of the intensity of psychedelic effects (MEQ30) 5-MeO-DM (a subjective description of psychedelic experiences) was recorded. Pharmacokinetic analysis of T and bufotenin plasma levels was performed 1 hour after drug administration in Part A. The test was performed 3 hours after the administration of the drug in Part B, and again 3 hours after the administration of the drug in Part B.

[0137] Participant characteristics: We recruited 18 participants for Part A of the study and 4 participants for Part B. (9 participants) The participants were female, and 13 participants were male. The median age was 29 years. (Age range: 19-42 years). In Part A, four participants were administered 2 mg of 5-MeO-DMT. Six participants were given 6 mg, and four participants were given 12 mg. In Part B, 18 mg of 5-MeO-DMT was administered to one participant. Two participants were given 6 mg, then 12 mg, and one participant was given 6 mg, then 12 mg. g, followed by a 18 mg dose.

[0138] result: All participants completed all scheduled visit days. In Part A, the inhalation procedure was 1 The procedure was performed correctly by 14 out of 8 participants, but two participants had a continuation of two inhalations. The procedure was followed, and the entire inhalation volume was inhaled. However, the two participants inhaled only about 3 / 4 of the total inhalation volume. In Part B, the inhalation procedure was performed correctly by 3 out of 4 participants, but 1 Although the participants performed appropriate inhalation at the first dose level, they did not perform total inhalation at the second dose level. Only about three-quarters of the inhaled dose was inhaled. No inhalation-related adverse events were reported.

[0139] Within seconds of inhalation, all participants experienced their first psychedelic symptoms. (External observation) The duration of the psychedelic experience, as judged by the individual, is between 7 and 30 minutes, and is dose-dependent. It was clear that there was no tendency for a chain reaction to occur.

[0140] Temporary, clinically unrelated increases in heart rate and blood pressure immediately after administration of 5-MeO-DMT Except for Sho, no significant changes occurred in vital parameters. ECG, safety experiment. The evaluation of room analysis, CADSS, and cognitive tests (PVT, DSST, PMT) was not significant. Ta.

[0141] All reported adverse events were mild (with the exception of one moderate event), and all were concluded at the end of the study. It spontaneously disappeared by the time of completion (Example 3 and Table 1 for Part A; Example for Part B) 3. Table 2). The overall tolerability profile of 5-MeO-DMT was very good. The 18 mg dose group in Part A had the highest number of adverse events, and this group was different On day 1 and day 7, only the following hallucinations and flashbacks of experiences were reported. It was observed that this was the dose group. In Part B, 5-MeO-DMT was administered up to three times a day. Despite administration, only a small number of adverse events were reported, and in fact, the dose was 18 mg (6 mg No adverse events were reported with the 12 mg dose (following the 12 mg dose).

[0142] [Table 7]

[0143] [Table 8]

[0144] Regarding the intensity of the psychedelic experience measured by PPEQ in Part A, PPEQ Individual questions, total PPEQ score, and percentage of patients who achieved a peak psychedelic experience. Dose-related trends were observed at the 2 mg, 6 mg, and 12 mg dose levels. However, at the 18 mg dose level, this dose-related trend is relevant to questions regarding loss of contr...

Claims

1. A composition for use in the treatment of a patient diagnosed with major depressive disorder by a qualified professional in accordance with accepted medical practice, comprising 5-methoxy-N,N-dimethyltryptamine (5-MeO-DMT) or a pharmaceutically acceptable salt thereof, which is administered intravenously, intramuscularly or subcutaneously, and which is in the form of a formulation for administration by injection.

2. The composition according to claim 1, wherein the disorder is diagnosed in accordance with the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) published by the American Psychiatric Association, or the disorder is diagnosed in accordance with other diagnostic criteria accepted in medical practice.

3. The composition according to claim 1 or 2, wherein the patient suffers from moderate or severe major depressive disorder as indicated by a Montgomery-Asberg Depression Rating Scale (MADRS) score of 20 or more prior to treatment, or by a Hamilton Depression Rating Scale (HAM-D) score of 17 or more items prior to treatment.

4. The composition according to claim 3, wherein the patient suffers from severe major depressive disorder as indicated by a pre-treatment MADRS score of 35 or higher, or a pre-treatment HAM-D score of 25 or higher.

5. The composition according to any one of claims 1 to 4, wherein the patient is diagnosed with treatment-resistant major depressive disorder.

6. The composition according to any one of claims 1 to 5, wherein the patient further suffers from suicidal ideation.

7. The composition according to any one of claims 1 to 6, wherein 5-MeO-DMT or a salt thereof is administered to the patient in a dose or dosage regimen that causes the patient to experience a supreme psychedelic experience.

8. The composition according to any one of claims 1 to 7, wherein 5-MeO-DMT or a salt thereof is administered in a first dose in a first administration, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent administrations.

9. The composition according to claim 8, wherein each subsequent dose uses a higher dosage than the previous dose.

10. The composition according to claim 8, wherein 5-MeO-DMT or a salt thereof is administered in a first dose in a first dose, and 5-MeO-DMT or a salt thereof is administered in 0 to 6 subsequent doses unless the patient experiences a supreme psychedelic experience.

11. The composition according to any one of claims 8 to 10, wherein the interval between two administrations is 1 hour or more and 24 hours or less.

12. The composition according to claim 11, wherein the interval between the two administrations is 1 to 4 hours.

13. The composition according to claim 12, wherein the interval between the two administrations is one hour.

14. The composition according to any one of claims 7 to 13, wherein the occurrence of a supreme psychedelic experience is identified by achieving at least 60% of the highest possible score on each of the four subscales (mystical, positive mood, spacetime transcendence and inexpressibility) of the 30-item Revised Mystical Experiences Questionnaire (MEQ30), or by achieving at least 60% of the highest possible score on the Oceanic Feeling (OBN) aspect of the Altered States of Consciousness (ASC) Questionnaire, or by achieving a total score of at least 75 Supreme Psychedelic Experiences Questionnaires (PPEQ).

15. The composition according to any one of claims 1 to 14, wherein 5-MeO-DMT or a pharmaceutically acceptable salt thereof is administered by intramuscular injection.

16. The composition according to any one of claims 1 to 15, wherein a clinical response, as determined by a score of at least “marked improvement” on the Clinical Global Impression-Improvement (CGI-I) score or the Patient's Global Impression-Improvement (PGI-I) score, occurs within two hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

17. The composition according to any one of claims 1 to 16, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

18. The composition according to any one of claims 1 to 17, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

19. The composition according to any one of claims 1 to 18, wherein a clinical response, as determined by a score of at least “marked improvement” on the CGI-I score or PGI-I score, is observed 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

20. The composition according to any one of claims 1 to 19, wherein a clinical response, as determined by an improvement of at least 50% in the MADRS or HAM-D score compared to the respective scores before treatment, occurs within two hours after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

21. The composition according to any one of claims 1 to 20, wherein remission of depressive symptoms, as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, occurs within two hours after the last dose of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

22. The composition according to any one of claims 1 to 21, wherein a clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score compared to the respective scores before treatment, is observed on the 7th day after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

23. The composition according to any one of claims 1 to 22, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present on day 7 after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

24. The composition according to any one of claims 1 to 23, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, seven days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

25. The composition according to any one of claims 1 to 24, wherein a clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score compared to the respective scores before treatment, is observed 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

26. The composition according to any one of claims 1 to 25, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

27. ​​The composition according to any one of claims 1 to 26, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 14 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

28. The composition according to any one of claims 1 to 27, wherein a clinical response, as determined by at least a 50% improvement in the MADRS or HAM-D score compared to the respective scores before treatment, is observed 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

29. The composition according to any one of claims 1 to 28, wherein a clinical response, as determined by an improvement of at least 75% in the MADRS or HAM-D score compared to the respective scores before treatment, is present 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

30. The composition according to any one of claims 1 to 29, wherein the patient is in remission of depressive symptoms as determined by a MADRS score of 10 or less or a HAM-D score of 7 or less, 28 days after the last administration of 5-MeO-DMT or a pharmaceutically acceptable salt thereof.

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