Trial record 10 of 25 for:    Open Studies | "Binge-Eating Disorder"

Armodafinil in Binge Eating Disorder (BED)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Lindner Center of HOPE
Sponsor:
Collaborators:
Cephalon
University of Cincinnati
Information provided by (Responsible Party):
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT01010789
First received: November 9, 2009
Last updated: November 13, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Binge Eating Disorder
Overweight
Obese
Drug: Armodafinil
Drug: Matching placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Primary Outcome Measures:
  • The primary efficacy variable is binge day frequency as assessed by take-home patient diary [ Time Frame: 12 treatment weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: November 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010789

Contacts
Contact: Susan McElroy, MD susan.mcelroy@lindnercenter.org
Contact: Anna Guerdjikova, PhD 513-536-0721 anna.guerdjikova@lindnercenter.org

Locations
United States, Ohio
Lindner Center of HOPE Recruiting
Mason, Ohio, United States
Sponsors and Collaborators
Lindner Center of HOPE
Cephalon
University of Cincinnati
  More Information

No publications provided

Responsible Party: Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT01010789     History of Changes
Other Study ID Numbers: Cephalon_001
Study First Received: November 9, 2009
Last Updated: November 13, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Binge-Eating Disorder
Bulimia
Eating Disorders
Overweight
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Body Weight
Modafinil
Central Nervous System Stimulants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on July 20, 2014