Treatment of Bulimia Nervosa in a Primary Care Setting

Bulimia Nervosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00009178
• Other study ID #: Walsh (completed)
• Secondary ID: R01DK053635-03
• Status: Completed
• Phase: N/A
• First received: January 23, 2001
• Last updated: January 12, 2010
• Start date: March 1998
• Est. completion date: December 2001

Study information

• Verified date: January 2010
• Source: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: December 2001
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bulimia
• Bulimia Nervosa

Intervention

Drug:
• Fluoxetine

Behavioral:
• Guided Self-Help

Locations

Country	Name	City	State
United States	New York State Psychiatric Institute	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation