Atomoxetine in the Treatment of Binge Eating Disorder

This study has been completed.
Sponsor:
Collaborator:
University of Cincinnati
Information provided by:
Lindner Center of HOPE
ClinicalTrials.gov Identifier:
NCT00327834
First received: May 17, 2006
Last updated: June 21, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Binge-eating Disorder
Drug: atomoxetine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients

Resource links provided by NLM:


Further study details as provided by Lindner Center of HOPE:

Study Start Date: May 2006
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 17, 2006
Last Updated: June 21, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 22, 2014