- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10032
- New York State Psychiatric Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Collaborators and Investigators
Investigators
- Principal Investigator: B. T. Walsh, MD, Columbia University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Feeding and Eating Disorders
- Hyperphagia
- Bulimia
- Bulimia Nervosa
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Cytochrome P-450 Enzyme Inhibitors
- Antidepressive Agents, Second-Generation
- Cytochrome P-450 CYP2D6 Inhibitors
- Fluoxetine
Other Study ID Numbers
- Walsh (completed)
- R01DK053635-03 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bulimia Nervosa
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University of California, San DiegoRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa | Atypical Bulimia NervosaUnited States
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Linnaeus UniversityGöteborg University; Linkoeping UniversityRecruitingBulimia Nervosa | Major Depression | Anorexia Nervosa/BulimiaSweden
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Yeshiva UniversityYale UniversityRecruitingAnorexia Nervosa | Bulimia Nervosa | Anorexia Nervosa, Atypical | Bulimia; AtypicalUnited States
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University Hospital, ToulouseUnknownAnorexia Nervosa/BulimiaFrance
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Maastricht UniversityZonMw: The Netherlands Organisation for Health Research and Development; Utrecht... and other collaboratorsRecruitingAnorexia Nervosa | Bulimia Nervosa | Atypical Anorexia Nervosa (Other Specified Eating Disorder) | Atypical Bulimia Nervosa (Other Specified Eating Disorder)Netherlands
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Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
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Rosemary Claire RodenChildren's Miracle NetworkEnrolling by invitationBulimia Nervosa | Impulsive Behavior | Purging (Eating Disorders) | Eating Disorders | Eating Disorders in Adolescence | Anorexia Nervosa/Bulimia | Anorexia in Adolescence | Anorexia Nervosa, Atypical | Anorexia Nervosa, Binge Eating/Purging TypeUnited States
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University Health Network, TorontoKlarman Family FoundationCompletedAnorexia Nervosa | Bulimia Nervosa
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Drexel UniversityNational Institute of Mental Health (NIMH)Active, not recruitingBinge-Eating Disorder | Bulimia Nervosa | Binge Eating | Bulimia; Atypical | Binge-Eating and Purging Type Anorexia NervosaUnited States
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University Health Network, TorontoTerminatedAnorexia Nervosa | Bulimia NervosaCanada
Clinical Trials on Fluoxetine
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Yale UniversityNational Institute of Mental Health (NIMH)RecruitingObsessive-Compulsive DisorderUnited States
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Chen QianRecruiting
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Nanfang Hospital, Southern Medical UniversityRecruiting
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Fundació Institut de Recerca de l'Hospital de la...Terminated
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Centre Hospitalier St AnneTerminated
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Teva Pharmaceuticals USACompleted
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Teva Pharmaceuticals USACompleted
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University of Sao PauloNovartis; Fundação de Amparo à Pesquisa do Estado de São Paulo; Conselho Nacional...CompletedObsessive Compulsive DisorderBrazil