Treatment of Bulimia Nervosa in a Primary Care Setting

This study has been completed.

First Received: January 23, 2001 Last Updated: June 23, 2005 History of Changes

Sponsored by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by:	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:	NCT00009178

Purpose

Bulimia Nervosa is a frequent problem for young women. It is widely assumed that this disorder cannot be treated effectively in a primary care setting.

This assumption has never been tested empirically, and is probably incorrect. In the last 15 years, effective treatment interventions for Bulimia Nervosa have been developed and validated in specialized treatment centers.

The broad aim of this proposal is to examine whether these treatments, suitably adapted, can be usefully transferred to general health care settings.

Specifically, the proposed study will determine the relative and combined effectiveness of the two leading treatments for Bulimia Nervosa in a primary care setting. The two major interventions are treatment with an antidepressant medication, fluoxetine, and with a form of cognitive behavioral therapy, guided self-help, designed for use in primary care.

Condition	Intervention
Bulimia Nervosa	Drug: Fluoxetine Behavioral: Guided Self-Help

Drug Information available for: Fluoxetine Fluoxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment

Further study details as provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Study Start Date:	March 1998
Estimated Study Completion Date:	December 2001

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

DSM-IV criteria for bulimia nervosa with a modified frequency criterion of at least once a week

Exclusion Criteria:

Physical disorder requiring hospitalization or ongoing treatment likely to affect eating and/or weight
Significant suicidal ideation or behavior
Subjects judged unable to tolerate four-month treatments available in the study because of comorbid psychiatric conditions
Current drug or alcohol dependence
Current anorexia nervosa
Pregnancy or any physical condition or treatments known to influence eating and weight
Current psychiatric treatment or medication known to affect eating or weight
Previous course of fluoxetine at a dose of 60 mg. per day for at least four weeks
Allergy to fluoxetine
Previous course of cognitive behavioral therapy for Bulimia Nervosa at a qualified center

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00009178

Locations

United States, New York
New York State Psychiatric Institute
New York, New York, United States, 10032

Sponsors and Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:

B. T. Walsh, MD

Columbia University

More Information

Additional Information:

Website for the Eating Disorders Clinic at the New York State Psychiatric Institute. Provides information about all of the programs offered by our institute for eating disorders. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

Publications:

Waller D, Fairburn CG, McPherson A, Kay R, Lee A, Nowell T. Treating bulimia nervosa in primary care: a pilot study. Int J Eat Disord. 1996 Jan;19(1):99-103.

Study ID Numbers:	Walsh, R01DK53635-03
Study First Received:	January 23, 2001
Last Updated:	June 23, 2005
ClinicalTrials.gov Identifier:	NCT00009178 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):

Primary Care
Fluoxetine

Study placed in the following topic categories:

Neurotransmitter Agents
Signs and Symptoms, Digestive
Psychotropic Drugs
Serotonin Uptake Inhibitors
Serotonin
Hyperphagia
Fluoxetine

Bulimia Nervosa
Signs and Symptoms
Mental Disorders
Bulimia
Antidepressive Agents, Second-Generation
Eating Disorders
Antidepressive Agents

Additional relevant MeSH terms:

Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Uptake Inhibitors
Pharmacologic Actions
Hyperphagia
Fluoxetine

Bulimia Nervosa
Signs and Symptoms
Serotonin Agents
Mental Disorders
Therapeutic Uses
Bulimia
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents
Eating Disorders

ClinicalTrials.gov processed this record on May 06, 2009