Treatment of Bulimia Nervosa in a Primary Care Setting

This study has been completed.
Sponsor:
Information provided by:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
ClinicalTrials.gov Identifier:
NCT00009178
First received: January 23, 2001
Last updated: January 12, 2010
Last verified: January 2010
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


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
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, see Learn About Clinical Studies.

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
Investigators
Principal Investigator: B. T. Walsh, MD Columbia University
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00009178     History of Changes
Other Study ID Numbers: Walsh (completed), R01DK53635-03
Study First Received: January 23, 2001
Last Updated: January 12, 2010
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Bulimia
Bulimia Nervosa
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Eating Disorders
Mental Disorders
Fluoxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 22, 2014