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Acamprosate in the Treatment of Binge-Eating Disorder

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: NCT00511940
Recruitment Status : Completed
First Posted : August 6, 2007
Last Update Posted : June 22, 2011
Forest Laboratories
University of Cincinnati
Information provided by:
Lindner Center of HOPE

Brief Summary:
The purpose of this research study is to determine the efficacy (how well it works), tolerability and safety of acomprosate compared with placebo in patients with binge eating disorder.

Condition or disease Intervention/treatment Phase
Binge Eating Disorder Drug: acamprosate Other: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : April 2007
Actual Primary Completion Date : January 2011
Actual Study Completion Date : January 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: 1
Drug: acamprosate
999 mg/day - 2997 mg/day, oral
Other Name: Campral

Placebo Comparator: 2
sugar pill
Other: placebo
oral, placebo

Primary Outcome Measures :
  1. The primary efficacy variable will be change in weekly binge frequency [ Time Frame: 10 weeks ]

Secondary Outcome Measures :
  1. Secondary efficacy variables will include change in binge day frequency (days during which at least one binge occurs), obsessive-compulsive symptoms of BED, craving for food, depressive symptoms, weight, and BMI [ Time Frame: 10 weeks ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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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:

  • Subjects will meet the DSM-IV (1) criteria for a diagnosis of binge eating disorder (BED) for at least the last 6 months. The DSM-IV 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 (eg, 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 (eg, 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 episodes per week for the last 6 months prior to randomization
  • Weight > 85% of the midpoint of ideal body weight for their height. (According to the Metropolitan Height/Weight table.) The subject population is expected to include both normal weight and obese individuals (although the majority of subjects are expected to be overweight).
  • Men or women, between the ages of 18 and 65. The subject population is expected to be predominantly made up of women.

Exclusion Criteria:

  • Have concurrent symptoms of bulimia nervosa or anorexia nervosa, including weight loss to at least 15% below the Metropolitan Height/Weight tables.
  • Women who are pregnant, lactating, or of childbearing potential who are not using adequate contraceptive measures. (All women of childbearing potential will have a negative pregnancy test before entering the study).
  • Patients who are displaying clinically significant suicidality or homicidality.
  • Patients who have received psychotherapy or behavioral therapy from a mental health professional as a part of previous treatment for BED for at least 3 months prior to randomization.
  • A DSM-IV diagnosis of substance abuse or dependence (except nicotine abuse or dependence) within the 6 months prior to randomization.
  • A lifetime DSM-IV history of psychosis, mania or hypomania, or dementia.
  • History of any psychiatric and 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. Patients should be biochemically euthyroid to enter the study.
  • History of seizures, including febrile seizures in childhood.
  • Patients requiring treatment with any drug which might interact adversely with or obscure the action of the study medication.
  • Clinically relevant abnormal laboratory results, specifically including hypokalemia.
  • Patients who have received monoamine oxidase inhibitors, antipsychotics, lithium, or fluoxetine within four weeks prior to randomization.
  • Patients who have received other psychoactive medications (other than hypnotics) within one week prior to randomization.
  • Patients who have received investigational medications or depot neuroleptics within three months prior to randomization.
  • Patients previously enrolled in this study or have previously been treated with acamprosate.

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): NCT00511940

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United States, Ohio
Lindner Center of HOPE
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Lindner Center of HOPE
Forest Laboratories
University of Cincinnati
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Principal Investigator: Susan L McElroy, MD Lindner Center of HOPE

Publications of Results:
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Responsible Party: Susan L. McElroy, MD, Lindner Center of HOPE Identifier: NCT00511940     History of Changes
Other Study ID Numbers: CMP-MD-20
First Posted: August 6, 2007    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
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Feeding and Eating Disorders
Binge-Eating Disorder
Mental Disorders
Signs and Symptoms, Digestive
Signs and Symptoms
Alcohol Deterrents