- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00327834
Atomoxetine in the Treatment of Binge Eating Disorder
June 21, 2011 updated by: Lindner Center of HOPE
Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients
The specific aim of this study is to assess the efficacy and safety of atomoxetine compared with placebo in outpatients with binge eating disorder.
Study Overview
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ohio
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Cincinnati, Ohio, United States, 45267-0559
- University of Cincinnati Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Susan L: McElroy, MD, University of Cincinnati
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2006
Primary Completion (Actual)
March 1, 2007
Study Completion (Actual)
March 1, 2007
Study Registration Dates
First Submitted
May 17, 2006
First Submitted That Met QC Criteria
May 17, 2006
First Posted (Estimate)
May 19, 2006
Study Record Updates
Last Update Posted (Estimate)
June 22, 2011
Last Update Submitted That Met QC Criteria
June 21, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Mental Disorders
- Signs and Symptoms, Digestive
- Hyperphagia
- Bulimia
- Feeding and Eating Disorders
- Binge-Eating Disorder
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Adrenergic Uptake Inhibitors
- Atomoxetine Hydrochloride
Other Study ID Numbers
- B4Z-US-X009
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.
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