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Treatment of Bulimia Nervosa in a Primary Care Setting

Primary Purpose

Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fluoxetine
Guided Self-Help
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bulimia Nervosa focused on measuring Primary Care, Fluoxetine

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • New York State Psychiatric Institute

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 23, 2001
Last Updated
January 12, 2010
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00009178
Brief Title
Treatment of Bulimia Nervosa in a Primary Care Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bulimia Nervosa
Keywords
Primary Care, Fluoxetine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Fluoxetine
Intervention Type
Behavioral
Intervention Name(s)
Guided Self-Help

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. T. Walsh, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8640208
Citation
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. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-L.
Results Reference
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Treatment of Bulimia Nervosa in a Primary Care Setting

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