Armodafinil in Binge Eating Disorder (BED)

Last updated: May 13, 2015
Sponsor: Lindner Center of HOPE
Overall Status: Completed

Phase

3

Condition

Bulimia

Binge Eating Disorder

Hypertriglyceridemia

Treatment

N/A

Clinical Study ID

NCT01010789
Cephalon_001
  • Ages 18-65
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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:

  2. Recurrent episodes of binge eating. An episode of binge eating is characterizedby both of the following: eating, in a discrete period of time (e.g., within anytwo hour period), an amount of food that is definitely larger than most peoplewould eat in a similar period of time under similar conditions; and a sense oflack of control over eating during the episode (e.g., a feeling that one cannotstop eating or control what or how much one is eating).

  3. The binge eating episodes are associated with at least three of the following:eating much more rapidly than normal; eating until uncomfortably full; eatinglarge amounts of food when not feeling physically hungry; eating alone because ofbeing embarrassed by how much one is eating; feeling disgusted with oneself,depressed, or feeling very guilty after overeating.

  4. Marked distress regarding binge eating.

  5. The binge eating occurs, on average, at least two days a week for six months.

  6. The episodes of binge eating do not occur exclusively during the course ofbulimia nervosa or anorexia nervosa.

  7. In addition, subjects will report at least 3 binge eating days per week for the 2weeks prior to randomization prospectively documented in take-home binge diaries. Abinge eating day (or binge day) is a day during which at least one binge eatingepisode occurs.

  8. Subjects will have a BMI ≥ 25. The subject population is expected to includeoverweight and obese individuals.

  9. Men or women, through the ages of 18 and 65 years, inclusive.

Exclusion

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 usingadequate contraceptive measures. All female subjects who still have a uterus will havea 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, cognitivebehavior therapy, interpersonal therapy) or weight loss (e.g., Weight Watchers,Overeaters Anonymous) intervention within the 3 months before study entry. Subjectswho are receiving psychotherapy that was initiated prior to 3 months of the beginningof the study will be allowed to continue to receive their psychotherapy during thetrial only if they agree to not make any changes to the frequency or nature of theirpsychotherapy during the course of the drug trial.

  5. A DSM-IV-TR diagnosis of substance abuse or dependence (except nicotine abuse ordependence) 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 whichcould interfere with diagnosis, treatment, or assessment of BED. Subjects should bebiochemically euthyroid to enter the study.

  9. Have a history of any major cardiovascular event in the past 6 months, includingunstable 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 theopinion of the physician investigator preclude study participation.

  13. Have clinically relevant abnormal laboratory results, specifically includinghypokalemia.

  14. Subjects who have a known allergy to armodafinil.

  15. Subjects requiring treatment with any drug which might interact adversely with orobscure 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) withinfour weeks prior to randomization, including monoamine oxidase inhibitors, tricyclics,selective serotonin reuptake inhibitors, antipsychotics, mood stabilizers, orpsychostimulants.

  17. Subjects who have received investigational medications or depot neuroleptics withinthree months prior to randomization

Study Design

Total Participants: 60
Study Start date:
November 01, 2009
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Lindner Center of HOPE

    Mason, Ohio
    United States

    Site Not Available

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