NCT00009178

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Mar 1998

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 1998

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

January 23, 2001

Completed
Same day until next milestone

First Posted

Study publicly available on registry

January 23, 2001

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2001

Completed
Last Updated

January 14, 2010

Status Verified

January 1, 2010

First QC Date

January 23, 2001

Last Update Submit

January 12, 2010

Conditions

Keywords

Primary CareFluoxetine

Interventions

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

Related 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. doi: 10.1002/(SICI)1098-108X(199601)19:13.0.CO;2-L.

    PMID: 8640208BACKGROUND

MeSH Terms

Conditions

Bulimia Nervosa

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • B. T. Walsh, MD

    Columbia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

January 23, 2001

First Posted

January 23, 2001

Study Start

March 1, 1998

Study Completion

December 1, 2001

Last Updated

January 14, 2010

Record last verified: 2010-01

Locations