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Therapeutic Treatment

Pending Publication Date: 2014-04-10
ATTENTIVE THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present patent text is about a treatment that can reduce appetite and increase a patient's attentiveness by at least 10%, 15%, 20%, 25%, 30%, 35%, 40%, 45%, 50%, 60%, 70%, 80%, 90%, or more. The treatment can also make a patient more attentive by about 10% to about 100%, 20% to about 100%, 30% to about 100%, 40% to about 100%, 50% to about 100%, or 60% to about 100%. This treatment can make a patient more aware and attentive while reducing their appetite.

Problems solved by technology

Although scientists and clinicians debate the best way to diagnose and treat ADHD, there is no debate among competent and well-informed health care professionals that ADHD is a valid neurobiological condition that causes significant impairment to children who suffer from it.
Untreated ADHD is to known to have significant long-term consequences including loss of academic performance, social performance, and more aberrant behaviors including substance abuse, teen pregnancies and imprisonment.
Among the functional impacts of ADHD in children and adolescents are a higher risk of injury, including, without limitation bicycle / pedestrian injury, head injury and multiple injuries that require admission to an intensive care unit.
Additionally, functional impacts of ADHD include a lack of friendships, less liked by their peers compared to non-ADHD peers, difficulty retaining peer status, a two times higher risk for tobacco smoking, a two and a half time higher risk for alcohol abuse, a two times higher risk for substance abuse, are four times more likely to contract an STD, a ten times higher risk for unplanned pregnancy, a two to six times higher rate of suspended or revoked driver's license, more traffic violations and speeding tickets, more motor vehicle accidents and greater vehicular damage.
Among the function impacts of ADHD in adults are similar to those found in children and adolescents, but also include a higher likelihood of being fired or quitting a job impulsively, reduced salary, poorer work performance scores, more frequent job changes, three times more likely to be unemployed, lower occupational attainment than patient IQ would predict.
While these drugs are generally effective in treating ADHD, the side effects suffered by the children taking them can include loss of appetite resulting in weight loss, insomnia, drug dependence and loss of attentiveness.
These are often used as an initial treatment in small children (<16 kg), but these drugs have the disadvantage of requiring that they be administered twice a day (“b.i.d.”) or three times a day (“t.i.d.”) to provide control over a child's ADHD symptoms throughout day.
Longer acting stimulants offer greater convenience, confidentiality, and compliance with single daily dosing, but the side effects suffered with these once a day drugs by children taking them is frequently more severe than the b.i.d. or t.i.d. ones.
But there are significant problems with therapeutic use of amphetamines and methylphenidates for the treatment of any neurological or psychological syndrome.
While this effect is perceived as positive by patients who are taking amphetamines as a weight loss medication, it can be detrimental to the health and proper development of children taking medications for ADHD and other psychiatric disorders.
For instance, overnight and morning fasting among schoolchildren was found to have a deleterious effect on the children's memory, attention, performance in academic pursuits and ability to interact with other children socially.
Patients with nutritional deficiencies are particularly susceptible to the short-term fluctuations in glucose supply that impact upon cognitive ability, attentiveness and performance of the brain.
However, this generally only works when the patient is not resistant to eating, for instance, due to loss of appetite.
Moreover, parents, spouse, or other caregiver cannot generally spend all day with a patient.
Particularly, where a patient suffers deleterious effects resulting from a loss of appetite including slower growth in their height, a slowing in their weight gain and a loss in the child's attentiveness.
One problem with this approach is that it can lead to the marked impairment of attentiveness by a patient during the periods of time when their ADHD medication is removed.
However, as these drugs are also often either an amphetamine or a methylphenidate, it is likely that the patient will suffer from the same side effects.
Among the side effects were weight gain and drowsiness.
Cyproheptadine has been shown to cause weight gain in studies that used either non-human animals or humans.
In ADHD, there is anecdotal evidence that a combination of an amphetamine or a methylphenidate and cyproheptadine as a treatment for children suffering from ADHD can result in weight gain and excessive sleep.
Additionally, the report did not analyze the impact on height.
Thus, though it is not reported in Daviss, it is likely that while the children gained weight, they did not see a cyproheptadine-related improvement in attentiveness during the day, particularly, while attending school.

Method used

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Examples

Experimental program
Comparison scheme
Effect test

example 1

Treatment of a Patient Suffering from ADHD with and without an Appetite Stimulant

[0164]A patient suffering from ADHD is prescribed and administered an amphetamine to treat ADHD. The patient takes the amphetamine once a day in the morning or afternoon. Following administration, the patient suffers a loss of appetite and reduces their caloric intake. As a result, the glucose level measured in the blood drops as shown in FIG. 1 and the patient suffers a lack of attentiveness as measured by CGI-S and CGI-I. When the patient is administered an amphetamine and Cyproheptadine once a day either in the morning or afternoon, the patient's appetite resumes and the patient increases their caloric intake. As a result, the glucose level measured in the blood increases as shown in FIG. 1 and the patient's attentiveness recovers as measured by CGI-S and CGI-I. By taking the appetite stimulant during the time when the patient was awake, the patient increased their caloric intake during times when th...

example 2

Once a Day Periactin

[0165]Case study: A six-year and ten month old girl was presented by her parents for symptoms of attention deficit hyperactivity disorder. Her size at evaluation was 4′1¾″ and 50 lbs, corresponding to the 81st and 50th percentiles when compared to girls her age. She responded well to treatment with various forms of methylphenidate, utilizing at various times both short-acting formulations, as well as a trial on a transdermal patch. A side-effect suffered by the girl was suppression of appetite and a lack of significant weight gain. At three months following the initiation of treatment for ADHD, the girl was 4′2⅞ and 50½ lbs, corresponding to the 85th and 34rd percentiles when compared to girls her age. At one year, she was 4′4⅜″ and 53 lbs, corresponding to the 84th and 36th percentiles when compared to girls her age. At two years she was 4′5¾″ and 54 lbs, corresponding to the 72nd and 17th percentiles when compared to girls her age. At four years of treatment sh...

example 3

Treatment of Patients Suffering from ADHD and Reduction in Appetite

[0167]Eight patients, identified as patients A-H, that came in suffering from ADHD were treated for ADHD. Each patient was prescribed an amphetamine or methylphenidate to treat ADHD and each patient following such treatment suffered a reduction in appetite and failed to gain sufficient weight. Each patient was then prescribed an appetite simulant to be taken along with the amphetamine or methylphenidate. The patients' weight, height and attentiveness were then followed during the course of treatment.

[0168]The age range of the patients was from 6-15 years of age, with a mean age at the start of treatment for ADHD of 8.4 years of age. The mean age at the start of the combination treatment wherein the patient was administered an amphetamine or methylphenidate and an appetite stimulant was 10.3 years of age. The mean treatment period for the eight patients was 1,108 days with a mean of 2.55 ADHD medication changes during...

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Abstract

This invention discloses a treatment for a patient receiving medication to treat an attention deficit disorder such as ADHD wherein the treatment results in a loss of appetite and impairment of the patient's attentiveness. The treatment combines a treatment for an attention deficit disorder with an appetite stimulant, wherein the appetite stimulant increases the caloric intake of a patient, which can increase the patient's attentiveness. The combination treatment can be given for an indefinite, including, without limitation, life-long, to allow a patient to maintain normal caloric intake during treatment for an attention deficit disorder.

Description

[0001]This application claims the benefit of priority to U.S. Provisional Patent Application 61 / 744,948, filed on Oct. 4, 2012, which is hereby incorporated by reference in its entirety.BACKGROUND[0002]To treat psychological and / or neurological disorders, including without limitation, attention deficit disorder, migrane, anti-serotonergic side effects, narcolepsy, excessive sleepiness associated with shift work, obstructive sleep apnea as an adjunct to continuous positive airways pressure (“CPAP”), exogenous obesity, disruptive behaviour disorder including oppositional defiant disorder (“ODD”) and conduct disorder (“CD”), obesity, depression, neural insult, fatigue, lethargy, binge eating disorder, schizophrenia, sleep cycle disorder, disease related fatigue in depression and fibromyalgia, cocaine addiction, Parkinson's Disease, combat and non-combat related PTSD, tic, and any other psychological and / or neurological syndrome it is common to prescribe to a patient a therapeutic regim...

Claims

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Application Information

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IPC IPC(8): A61K45/06A61K31/165A61K31/137A61K31/451A61K31/4458
CPCA61K45/06A61K31/451A61K31/165A61K31/137A61K31/4458A61P25/00A61K2300/00
Inventor SEARS, DOUGLASREILLY, MICHAEL
Owner ATTENTIVE THERAPEUTICS INC
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