Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder

• Status: Completed
• Trial end date: 2007-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Baclofen

Criteria

Inclusion Criteria:

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 Criteria:

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)