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Atomoxetine in the Treatment of Binge Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00327834
Recruitment Status : Completed
First Posted : May 19, 2006
Last Update Posted : June 22, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
The specific aim of this study is to assess the efficacy and safety of atomoxetine compared with placebo in outpatients with binge eating disorder.

Condition or disease Intervention/treatment Phase
Binge-eating Disorder Drug: atomoxetine Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients
Study Start Date : May 2006
Primary Completion Date : March 2007
Study Completion Date : March 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects will meet the DSM-IV criteria for a diagnosis of binge-eating disorder for at least the last 6 months
  • In addition, subjects will report at least 3 binge eating episodes per week for the last 6 months prior to randomization

Exclusion Criteria:

  • Have concurrent symptoms of bulimia nervosa or anorexia nervosa
  • Women who are pregnant, lactating, or of child bearing potential who are not using adequate contraceptive measures
  • Patients who are displaying clinically significant suicidality or homicidality
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00327834


Locations
United States, Ohio
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45267-0559
Sponsors and Collaborators
Lindner Center of HOPE
University of Cincinnati
Investigators
Principal Investigator: Susan L: McElroy, MD University of Cincinnati
More Information

Publications:
Responsible Party: Susan McElroy, Lindner Center of HOPE
ClinicalTrials.gov Identifier: NCT00327834     History of Changes
Other Study ID Numbers: B4Z-US-X009
First Posted: May 19, 2006    Key Record Dates
Last Update Posted: June 22, 2011
Last Verified: June 2011

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Bulimia
Binge-Eating Disorder
Pathologic Processes
Mental Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Atomoxetine Hydrochloride
Adrenergic Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs