Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Phase 1

Completed

• Conditions: Major Depressive Disorder
• Interventions: Drug: Placebo; Drug: Escitalopram; Drug: Pexacerfont

• Registration Number: NCT00135421
• Lead Sponsor: Bristol-Myers Squibb

Brief Summary

The purpose of this clinical research study is to learn whether BMS-562086 is both safe and effective in treating outpatients with major depressive disorder.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-08-25
• Study First Submitted QC: 2005-08-25
• Study First Posted: 2005-08-26
• Study Start: 2005-11
• Primary Completion: 2007-10
• Study Completion: 2007-10
• Status Verified: 2008-09
• Disposition First Submitted: 2010-02-27
• Disposition First Submitted QC: 2010-02-27
• Last Update Submitted: 2010-02-27
• Disposition First Posted: 2010-03-02
• Last Update Posted: 2010-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 271

Inclusion Criteria

• Outpatient women meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for a single or recurrent, non-psychotic episode of Major Depressive Disorder (296.2x and 296.3x).
• Patients whose current depressive episode is at least three months in duration at the Baseline Visit.

Exclusion Criteria

• Males
• Patients with treatment resistance to other antidepressants

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A3	Placebo	-
A2	Escitalopram	-
A1	Pexacerfont	-

Primary Outcome Measures

Name	Time	Method
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)	Week 8

Secondary Outcome Measures

Name	Time	Method
Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests	every visit and endpoint
Compare efficacy of escitalopram to placebo	at endpoint and at each visit

Trial Locations

Locations (40)

Apc Clinical Research Trials Nw, Pa; 🇺🇸 Springdale, Arkansas, United States

Pacific Clinical Research Medical Group; 🇺🇸 Upland, California, United States

Front Range Clinical Research; 🇺🇸 Wheatridge, Colorado, United States

University Of Connecticut Health Center; 🇺🇸 Farmington, Connecticut, United States

University Of Florida; 🇺🇸 Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.; 🇺🇸 Memphis, Tennessee, United States

Emory University; 🇺🇸 Atlanta, Georgia, United States

Cunningham Clinical Research, Llc; 🇺🇸 Edwardsville, Illinois, United States

Alexian Center For Psychiatric Research; 🇺🇸 Hoffman Estates, Illinois, United States

American Medical Research, Inc.; 🇺🇸 Oakbrook, Illinois, United States

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