Armodafinil in Binge Eating Disorder (BED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010789
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : May 14, 2015
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE

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

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Overweight Obese Drug: Armodafinil Drug: Matching placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : November 2014
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Armodafinil
Flexible dose 150-250mg/day
Drug: Armodafinil
flexible dose 150-250mg/day

Drug: Armodafinil
150-250mg/day; flexible dose

Placebo Comparator: Mathing Placebo Drug: Matching placebo
Placebo comparator

Primary Outcome Measures :
  1. The primary efficacy variable is binge day frequency as assessed by take-home patient diary [ Time Frame: 12 treatment weeks ]

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

Inclusion Criteria: Criteria for entering this study will include all of the following:

  1. 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:

    1. 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).
    2. 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.
    3. Marked distress regarding binge eating.
    4. The binge eating occurs, on average, at least two days a week for six months.
    5. The episodes of binge eating do not occur exclusively during the course of bulimia nervosa or anorexia nervosa.
  2. 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.
  3. Subjects will have a BMI ≥ 25. The subject population is expected to include overweight and obese individuals.
  4. Men or women, through the ages of 18 and 65 years, inclusive.

Exclusion Criteria:

  1. Have concurrent symptoms of bulimia nervosa or anorexia nervosa.
  2. 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.
  3. Subjects who are displaying clinically significant suicidality or homicidality.
  4. 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.
  5. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
  6. A lifetime DSM-IV-TR history of psychosis, mania or hypomania, or dementia.
  7. History of any psychiatric or personality disorder (eg, schizotypal and borderline) which might interfere with a diagnostic assessment, treatment, or compliance.
  8. 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.
  9. Have a history of any major cardiovascular event in the past 6 months, including unstable angina, acute myocardial infarction, coronary angioplasty, or stroke.
  10. History of seizures, including clinically febrile seizures in childhood.
  11. Have uncontrolled hypertension (>160/100) or tachycardia (heart rate >110).
  12. Have an ECG with significant arrhythmias or conduction abnormalities, which in the opinion of the physician investigator preclude study participation.
  13. Have clinically relevant abnormal laboratory results, specifically including hypokalemia.
  14. Subjects who have a known allergy to armodafinil.
  15. 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.
  16. 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.
  17. Subjects who have received investigational medications or depot neuroleptics within three months prior to randomization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01010789

United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Lindner Center of HOPE Identifier: NCT01010789     History of Changes
Other Study ID Numbers: Cephalon_001
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Feeding and Eating Disorders
Binge-Eating Disorder
Body Weight
Signs and Symptoms
Mental Disorders
Signs and Symptoms, Digestive
Wakefulness-Promoting Agents
Central Nervous System Stimulants
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action