Status:
COMPLETED
Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder
Lead Sponsor:
New York State Psychiatric Institute
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Eating Disorders
Bulimia Nervosa
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness of the drug baclofen in reducing binge eating and associated food cravings in people with bulimia nervosa or binge eating disorder.
Detailed Description
Bulimia nervosa (BN) and binge eating disorder (BED) are serious eating disorders that are characterized by frequent uncontrolled eating binges. Binge eating is associated with both psychological and ...
Eligibility Criteria
Inclusion
- For people with BN:
- Meets DSM-IV criteria for BN
- Disease duration is more than 1 year
- Self-induces vomiting
- Weighs between 80 and 120% of ideal weight
- Binge eats on at least 6 days during the 2-week run-in period
- For obese people with BED:
- Meets DSM-IV criteria for BED
- Obese (body mass index \[BMI\] is greater than 30 kg/m²)
- Binge eats on at least 6 days during the 2-week run-in period
Exclusion
- For all participants:
- Significant medical illness
- Current or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder as defined by DSM-IV-TR
- Moderate to severe depression as defined by a score greater than 18 on the Hamilton Depression Scales
- Current DSM-IV-TR diagnosis of organic mental disorder, factitious disorder, or malingering
- History of a personality disorder (e.g., schizotypal, borderline, or antisocial) that might interfere with assessment or compliance with the study procedures
- At risk for suicide
- Currently taking medication other than birth control pills or over-the-counter medication
- History of drug or alcohol abuse within 3 months prior to study entry
- Pregnant, planning to become pregnant, or breast feeding
- Known intolerance to baclofen, or related muscle relaxants
- Orthostatic hypotension
- Additional exclusion criteria for people with BN:
- Underweight (BMI less than 18 kg/m²)
Key Trial Info
Start Date :
April 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00320047
Start Date
April 1 2005
End Date
June 1 2007
Last Update
August 12 2013
Active Locations (1)
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1
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032