Armodafinil in Binge Eating Disorder (BED)

NCT01010789 | Completed Phase 3

• 1 other identifier: Cephalon_001
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Binge Eating Disorder; Overweight; Obese

Outcome Measures

Primary Outcomes (1)

• The primary efficacy variable is binge day frequency as assessed by take-home patient diary

  12 treatment weeks

Study Arms (2)

Armodafinil

EXPERIMENTAL

Flexible dose 150-250mg/day

Drug: Armodafinil

Mathing Placebo

PLACEBO COMPARATOR

Drug: Matching placebo

Interventions

Armodafinil DRUG

flexible dose 150-250mg/day

Armodafinil

Matching placebo DRUG

Placebo comparator

Mathing Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lindner Center of HOPE: lead
• Cephalon: collaborator
• University of Cincinnati: collaborator

Study Sites (1)

Lindner Center of HOPE

Mason, Ohio, United States

Location

Related Publications (1)

• McElroy SL, Guerdjikova AI, Mori N, Blom TJ, Williams S, Casuto LS, Keck PE Jr. Armodafinil in binge eating disorder: a randomized, placebo-controlled trial. Int Clin Psychopharmacol. 2015 Jul;30(4):209-15. doi: 10.1097/YIC.0000000000000079.

  PMID: 26011779 DERIVED

MeSH Terms

Conditions

Binge-Eating Disorder; Overweight; Obesity

Interventions

Modafinil

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzhydryl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2009
• First Posted: November 10, 2009
• Study Start: November 1, 2009
• Primary Completion: November 1, 2014
• Study Completion: May 1, 2015
• Last Updated: May 14, 2015

Record last verified: 2015-05

Locations

US (1)