Effectiveness of Baclofen in the Treatment of People With Bulimia Nervosa or Binge Eating Disorder - Full Text View

Sponsor:	National Institute of Mental Health (NIMH)
Information provided by:	National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:	NCT00320047

Purpose

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.

Condition	Intervention
Eating Disorders Bulimia Nervosa	Drug: Baclofen

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Effects of Baclofen on Binge Eating in Bulimia Nervosa and Binge Eating Disorder

Resource links provided by NLM:

MedlinePlus related topics: Eating Disorders

Drug Information available for: Baclofen

U.S. FDA Resources

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:

Frequency of binge eating [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Cravings associated with binge eating [ Time Frame: Measured at Week 13 ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	April 2005
Study Completion Date:	June 2007
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Participants will take baclofen for 10 weeks.	Drug: Baclofen 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.

Arms

Assigned Interventions

Experimental: 1

Participants will take baclofen for 10 weeks.

Drug: Baclofen

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.

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 physical health problems, such as depression, obesity, stomach problems, and heart problems. Treatment options for binge eating, however, are limited. Baclofen, a drug that enhances the GABA-B neurotransmitter's ability to inhibit neuronal activity in the brain, is commonly used as a muscle relaxant. It has also been shown, however, to have positive effects on binge eating when used in animals and on substance abuse when used in humans. This study will evaluate the effectiveness of baclofen in reducing binge eating and associated food cravings in people with BN or BED.

People interested in participating in this study will first report to the study site for two initial visits, which will involve blood tests and interviews regarding medical history. If eligible, participants will take part in this 13-week open-label study. 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. Participants will also keep a daily record of any episodes of binge eating. Study visits will be held biweekly. At each visit, participants will be interviewed by a psychiatrist about their mental health history and eating patterns, and will fill out questionnaires about their eating habits, emotional states, and any side effects. Phone interviews will be conducted during the weeks in between study visits.

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00320047

Locations

United States, New York
Eating Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Mental Health (NIMH)

Investigators

Principal Investigator:

B. T. Walsh, MD

New York State Psychiatric Institute at Columbia University Medical Center

More Information

No publications provided

Responsible Party:	Dr. B. Timothy Walsh, The New York State Psychiatric Institute
ClinicalTrials.gov Identifier:	NCT00320047 History of Changes
Other Study ID Numbers:	R21 MH65024-06, DNBBS 72-NBR
Study First Received:	April 28, 2006
Last Updated:	September 18, 2009
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):

Binge Eating Disorder

Additional relevant MeSH terms:

Bulimia
Bulimia Nervosa
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders
Baclofen
GABA-B Receptor Agonists
GABA Agonists

GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Muscle Relaxants, Central
Neuromuscular Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012