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Treatments For Depression And Other Diseases With A Low Dose Agent

a low-dosage agent and treatment technology, applied in the direction of biocide, drug composition, metabolic disorder, etc., can solve the problems of depression symptoms that are difficult to stay focused and paying attention, and depression symptoms that are difficult to cope with

Inactive Publication Date: 2015-12-03
PHARMORX THERAPEUTICS
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Left untreated, depression can lead to serious impairment in daily functioning and even suicide.
Without treatment, the frequency and severity of depression symptoms tend to increase over time.
Symptoms include difficulty staying focused and paying attention, difficulty controlling behavior, and hyperactivity (over-activity).
Obesity is a disorder marked by excessive body fat that negatively affects a patient's health.
Unfortunately, sufficient treatment for these disorders has proven elusive.
For instance, in the context of depression, while certain pharmaceuticals have proven somewhat successful, medical practitioners face the challenge of unpredictable responses and eventual loss of effect, necessitating constant evaluation of treatments and, often, changes in treatment regimens.
Further, anti-depression pharmaceuticals are often characterized by unpleasant side effects.

Method used

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  • Treatments For Depression And Other Diseases With A Low Dose Agent

Examples

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Effect test

example 1

Patient Responses to Low Dose Naltrexone Treatment of Depression

[0155]Patient #1: A middle aged female suffered severe depression with recurrent major depressive episodes. She had responded briefly to complex polypharmacy and electroconvulsive therapy, but depression usually returned within 3 weeks of these interventions. In addition to restarting aripiprazole (ABILIFY), to which she had transiently responded in the past, the patient was instructed to pulverize a tablet of naltrexone 50 mg, and take the smallest fragment with water. A sample of these fragments was later weighed, indicating she was taking on the average about 1 mg of naltrexone daily. The former pharmacologic regimen was otherwise unchanged.

[0156]About one week after initiating low dose naltrexone, the patient experienced marked remission. Despite minor variation in mood, she has maintained the remission for more than 6 months (continuing to present). She has remained on adjunctive naltrexone 1 mg daily.

[0157]Patient...

example 2

Clinical Testing of Low Dose Naltrexone Treatment of Depression

[0165]The clinical studies described herein, in part, assess the magnitude and rate of response to low dose naltrexone, as measured by change on the HAM-D-17, compared to placebo. Low dose naltrexone possesses a unique antidepressant signature distinct from the more gradual rates of symptom change characteristic of both placebo response and response to first-line antidepressant agents.

[0166]The trial is conducted over 6 weeks, with double-blind treatment divided into two phases of 3 weeks each; this interval of 3 weeks was chosen based on the rapid course of recovery described in the case reports above. The first phase consists of a 1:1 randomization between placebo (n=18) and active treatment (n=18). Entering phase 2, all placebo non-responders are switched to low dose naltrexone.

[0167]12 men and women ages 18 to 65 who have received adequately dosed SSRI (optionally in combination with a dopaminergic agent), or a selec...

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Abstract

The present invention relates to improved compositions and methods for the treatment or prevention of various diseases, including forms of depression, including, for example, breakthrough depression and treatment-refractory depression, and other mood disorders, as well Parkinson's disease, bipolar disorder, bipolar disorder, attention deficit disorder (ADHD), Restless Leg Syndrome (RLS), and obesity. In some embodiments, the compositions and methods comprise low dose naltrexone or related opioid antagonists.

Description

PRIORITY[0001]The present application claims priority to U.S. Provisional Application No. 61 / 758,551, filed on Jan. 30, 2013 and U.S. Provisional Application No. 61 / 814,476, filed on Apr. 22, 2013, the contents of which are herein incorporated by reference in their entireties. The present application is related to U.S. Ser. No. 12 / 603,235, filed Oct. 21, 2009 and U.S. Ser. No. 13 / 758,569, filed Feb. 4, 2013, the contents of which are incorporated by reference in their entireties.FIELD OF THE INVENTION[0002]The present invention relates to compositions and methods that are useful in treating various forms of depression and other disorders.BACKGROUND[0003]Mental illnesses and obesity are increasing prevalent disorders in the modern world and require improved treatments to maximize patient quality of life and reduce health care costs.[0004]For instance, depression refers to a serious medical illness that affects one's thoughts, feelings, behavior, mood and physical health. Major depres...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K31/485
CPCA61K31/485A61K31/135A61K31/137A61K31/138A61K31/15A61K31/165A61K31/343A61K31/381A61K31/4045A61K31/428A61K31/4406A61K31/4525A61K31/454A61K31/496A61K45/06A61P3/04A61P25/00A61P25/16A61P25/24A61P43/00A61K2300/00A61K9/0053
Inventor BEAR, DAVID MKESSLER, ROBERT M.
Owner PHARMORX THERAPEUTICS
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