Working… Menu

Treatment of Bulimia Nervosa in a Primary Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00009178
Recruitment Status : Completed
First Posted : January 23, 2001
Last Update Posted : January 14, 2010
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Brief Summary:

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 or disease Intervention/treatment Phase
Bulimia Nervosa Drug: Fluoxetine Behavioral: Guided Self-Help Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Study Start Date : March 1998
Study Completion Date : December 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoxetine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00009178

Layout table for location information
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)
Layout table for investigator information
Principal Investigator: B. T. Walsh, MD Columbia University

Layout table for additonal information Identifier: NCT00009178     History of Changes
Other Study ID Numbers: Walsh (completed)
R01DK053635-03 ( U.S. NIH Grant/Contract )
First Posted: January 23, 2001    Key Record Dates
Last Update Posted: January 14, 2010
Last Verified: January 2010
Keywords provided by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK):
Primary Care
Additional relevant MeSH terms:
Layout table for MeSH terms
Bulimia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Cytochrome P-450 CYP2D6 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors