Method of treating depressive disorders

Abstract

The invention provides methods of treating depressive disorders, in particular major depression but other depressive orders also, with prodrug stimulants or analogs including amphetamine prodrugs, methylphenidate prodrugs, and methylphenidate analogs, Such methods of treatment may utilize the prodrug stimulant or analog as monotherapy or, more commonly, as an adjunct to antidepressant medication treatment to augment their effect. The invention includes combination methods of treatment in which an amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog is administered to an individual in need with one or more other active agents, either in separate forms or as a single pharmaceutical formulation. Packaged pharmaceutical compositions containing an amphetamine or methylphenidate prodrug, instructions for using the prodrug to treat certain disorders, and optionally one or more other active agents are provided by the invention.

Description

FIELD OF INVENTION[0001]The inventor has discovered that amphetamine prodrugs and methylphenidate prodrugs are useful for treating a number of central nervous system disorders. Methods of treating binge eating disorders, obesity resulting from binge eating behavior, and depression are included herein. The invention includes methods of treating certain co-morbidities in ADHD (Attention-Deficit Hyperactivity Disorder) and ADD patients; for example the invention includes methods of treating generalized anxiety disorder, obsessional and ruminative thought disorders, and obsessive / compulsive behavior in ADHD and ADD patients. Methods of treatment include methods in which the amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog is the only active agent. The invention also includes combination methods of treatment in which an amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog is administered with one or more other active agents. Methods of use descri...

AI Technical Summary

Benefits of technology

[0012]The inventor has discovered that amphetamine prodrugs, including lisdexamfetamine dimesylate, methylphenidate prodrugs, and certain methylphenidate analogs, are useful for treating binge eating disorders, obesity resulting from binge eating behavior, and depression. Furthermore amphetamine prodrugs, methylphenidate prodrugs, and certain methylphenidate analogs have been found useful for treating certain co-morbidities in ADHD and ADD patients. The invention includes methods of treating generalized anxiety disorder, obsessional and ruminative thought disorders, and obsessive / compulsive behavior in patients, particularly in ADHD / ADD patients. Methods of using amphetamine prodrugs, methylphenidate prodrugs, or methylphenidate analogs, as a monotherapy for treating these conditions and disorders or in combination with one or more other active agents are provided herein.

[0013]The invention includes a method of treating binge eating disorder or obesity resulting from binge eating behavior, comprising diagnosing a patient as having a binge eating disorder or obesity resulting from binge eating behavior and providing an effective amount of amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog to the patient.

[0014]The invention also includes a method of treating depression comprising diagnosing a patient as having depression and providing an effective amount of amphetamine prodrug, methylphenidate prodrug, methylphenidate analog to the patient.

[0015]The invention further provides a method of treating generalized anxiety disorder, obsessional and ruminative thought disorders, or obsessive / compulsive behavior in a patient having ADHD or ADD or other patient. In an ADHD or ADD patient this method comprises diagnosing a patient having ADHD or ADD and as also having at least one of generalized anxiety disorder, obsessional and ruminative thought disorders, or obsessive / compulsive behavior, and providing an effective amount of amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog to the patient.

[0016]In each of these methods the amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog may be provided as the only active agent, i.e. as a monotherapy, or may be provided together with one or more other active agents, i.e. as a combination, adjunct, or augmentation therapy.

[0017]In a separate embodiment, the invention includes a method of using an amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog comprising informing a user that the amphetamine prodrug, methylphenidate prodrug, methylphenidate analog may be used to treat binge eating disorder or obesity resulting from binge eating behavior. The invention also includes a method of using an amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog comprising informing a user that the amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog may be used to treat depression. The invention further includes a method of using an amphetamine prodrug, methylphenidate prodrug, or methylphenidate analog comprising informing a user that the amphetamine prodrug, methylphenidate prodrug, methylphenidate analog may be used to treat certain co-morbidities in ADHD and ADD patients, or may be used to treat certain CNS disorders in patients not diagnosed with ADHD or ADD, including generalized anxiety disorder, obsessional and ruminative thought disorders, and obsessive / compulsive behavior. The invention includes (i) lisdexamfetamine dimesylate and (ii) one or more other active agent(s) combined in a single dosage form.

Problems solved by technology

Binge eating also may cause rapid and unhealthy weight gain (or loss), weight fluctuations, and chronic erratic eating behavior.

Binge eating disorder is difficult to treat and carries significant medical and psychiatric risks.

Pharmacologic interventions have been of limited success and sometimes cause a worsening of binge eating symptoms.

Depression is often difficult to treat, as some patients fail to respond to an initial pharmacologic intervention and a decision must be made to switch agents, augment with another medication(s), or combine multiple pharmacologic agents.

Combining medications, while often helpful, can sometimes be problematic with added side effect burdens.

Some patients may be ‘refractory’ or ‘resistant’ to treatment and fail to respond to one, or in some cases, multiple monotherapy and combination antidepressant medication treatments.

Major depressive disorders similarly may lead to deteriorating physical health and may increase the risk of morbidity and mortality in patients with concurrent medical conditions.

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