Armodafinil in Binge Eating Disorder (BED)

Study Overview
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Brief Summary
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The purpose of this research study is to study the effectiveness, tolerability and safety of armodafinil in outpatients with binge eating disorder.

Conditions
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Binge Eating Disorder, Overweight, Obese

Intervention / Treatment
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* Drug: Armodafinil
* Drug: Armodafinil
* Drug: Matching placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: Criteria for entering this study will include all of the following: Subjects will meet the DSM-IV-TR criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV-TR criteria are as follows: Recurrent episodes of binge eating. An episode of binge eating is characterized by both of the following: eating, in a discrete period of time (e.g., within any two hour period), an amount of food that is definitely larger than most people would eat in a similar period of time under similar conditions; and a sense of lack of control over eating during the episode (e.g., a feeling that one cannot stop eating or control what or how much one is eating). The binge eating episodes are associated with at least three of the following: eating much more rapidly than normal; eating until uncomfortably full; eating large amounts of food when not feeling physically hungry; eating alone because of being embarrassed by how much one is eating; feeling disgusted with oneself, depressed, or feeling very guilty after overeating. Marked distress regarding binge eating. The binge eating occurs, on average, at least two days a week for six months. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa. In addition, subjects will report at least 3 binge eating days per week for the 2 weeks prior to randomization prospectively documented in take-home binge diaries. A binge eating day (or binge day) is a day during which at least one binge eating episode occurs. Subjects will have a BMI ≥ 25. The subject population is expected to include overweight and obese individuals. Men or women, through the ages of 18 and 65 years, inclusive. Exclusion Criteria: Have concurrent symptoms of bulimia nervosa or anorexia nervosa. Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. All female subjects who still have a uterus will have a negative pregnancy test prior to randomization. Subjects who are displaying clinically significant suicidality or homicidality. Subjects who have begun a new psychological (e.g., supportive psychotherapy, cognitive behavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers, Overeaters Anonymous) intervention within the 3 months before study entry. Subjects who are receiving psychotherapy that was initiated prior to 3 months of the beginning of the study will be allowed to continue to receive their psychotherapy during the trial only if they agree to not make any changes to the frequency or nature of their psychotherapy during the course of the drug trial. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization. A lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia. History of any psychiatric or personality disorder (eg, schizotypal and borderline) which might interfere with a diagnostic assessment, treatment, or compliance. Clinically unstable medical disease, including cardiovascular, hepatic, renal, gastrointestinal, pulmonary, metabolic, endocrine or other systemic disease which could interfere with diagnosis, treatment, or assessment of BED. Subjects should be biochemically euthyroid to enter the study. Have a history of any major cardiovascular event in the past 6 months, including unstable angina, acute myocardial infarction, coronary angioplasty, or stroke. History of seizures, including clinically febrile seizures in childhood. Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110). Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation. Have clinically relevant abnormal laboratory results, specifically including hypokalemia. Subjects who have a known allergy to armodafinil. Subjects requiring treatment with any drug which might interact adversely with or obscure the action of the study medication. This includes warfarin, anticonvulsants, clonidine, theophylline, and pseudoephedrine. Subjects who have received any psychotropic medications (other than hypnotics) within four weeks prior to randomization, including monoamine oxidase inhibitors, tricyclics, selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, or psychostimulants. Subjects who have received investigational medications or depot neuroleptics within three months prior to randomization

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Armodafinil<br>Flexible dose 150-250mg/day | Drug: Armodafinil<br>* flexible dose 150-250mg/day<br>Drug: Armodafinil<br>* 150-250mg/day; flexible dose<br>|
| Placebo Comparator: Mathing Placebo<br> | Drug: Matching placebo<br>* Placebo comparator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary efficacy variable is binge day frequency as assessed by take-home patient diary |  | 12 treatment weeks |