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

NCT00320047 | Completed

• 3 other identifiers: #5017R21MH065024DNBBS 72-NBR
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Eating Disorders; Bulimia Nervosa

Keywords

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• Frequency of binge eating

  Measured at Week 13

Secondary Outcomes (1)

• Cravings associated with binge eating

  Measured at Week 13

Study Arms (1)

1

EXPERIMENTAL

Participants will take baclofen for 10 weeks.

Drug: Baclofen

Interventions

Baclofen DRUG

Participants will take baclofen 3 times a day, before meals, for 10 weeks. Baclofen dosages will be low to begin, followed by a gradual increase over a 2-week period. Upon reaching the maximum tolerated dose of baclofen, participants will continue at this dosage level until Week 11, at which time the dose will be gradually decreased. If any serious side effects occur, baclofen dosage will be decreased to the previous tolerated dosage level.

1

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Underweight (BMI less than 18 kg/m²)

Sponsors & Collaborators

• New York State Psychiatric Institute: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Eating Disorders Clinic, New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders; Bulimia Nervosa; Binge-Eating Disorder

Interventions

Baclofen

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Officials

• B. T. Walsh, MD

  New York State Psychiatric Institute at Columbia University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2006
• First Posted: April 27, 2006
• Study Start: April 1, 2005
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2007
• Last Updated: August 12, 2013

Record last verified: 2008-09

Locations

US (1)