Atomoxetine in the Treatment of Binge Eating Disorder

Binge-eating Disorder Clinical Trial

Official title:

Atomoxetine in the Treatment of Binge Eating Disorder: A Single-Center, Double-Blind, Placebo-Controlled, Flexible Dose Study in Outpatients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00327834
• Other study ID #: B4Z-US-X009
• Status: Completed
• Phase: Phase 4
• First received: May 17, 2006
• Last updated: June 21, 2011
• Start date: May 2006
• Est. completion date: March 2007

Study information

• Verified date: June 2011
• Source: Lindner Center of HOPE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

• Binge-eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders

Intervention

Drug:
• atomoxetine

Locations

Country	Name	City	State
United States	University of Cincinnati Medical Center	Cincinnati	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Lindner Center of HOPE	University of Cincinnati

Country where clinical trial is conducted

United States, 

References & Publications (1)

McElroy SL, Guerdjikova A, Kotwal R, Welge JA, Nelson EB, Lake KA, Keck PE Jr, Hudson JI. Atomoxetine in the treatment of binge-eating disorder: a randomized placebo-controlled trial. J Clin Psychiatry. 2007 Mar;68(3):390-8. — View Citation