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OpenTrials
Completed

NCT Number: NCT00009178

Treatment of Bulimia Nervosa in a Primary Care Setting

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.

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Key information

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

New York State Psychiatric Institute

New York, 10032, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoxetine

Drug

Guided Self-Help

Behavioral

Sponsors and collaborators

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Nih

Registry information

Important dates

Study start
1998
Study completion
2001
First posted
Jan 23, 2001
Registry last updated
Jan 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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