NCT00327834

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started May 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 19, 2006

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2007

Completed
Last Updated

June 22, 2011

Status Verified

June 1, 2011

Enrollment Period

10 months

First QC Date

May 17, 2006

Last Update Submit

June 21, 2011

Conditions

Binge-eating Disorder

Interventions

atomoxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267-0559, United States

Location

Related 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. doi: 10.4088/jcp.v68n0306.

    PMID: 17388708RESULT

MeSH Terms

Conditions

Binge-Eating Disorder

Interventions

Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Feeding and Eating DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Susan L: McElroy, MD

    University of Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 17, 2006

First Posted

May 19, 2006

Study Start

May 1, 2006

Primary Completion

March 1, 2007

Study Completion

March 1, 2007

Last Updated

June 22, 2011

Record last verified: 2011-06

Locations

US(1)