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

Major Depressive Disorder Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00135421
• Other study ID #: CN148-007
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 25, 2005
• Last updated: February 27, 2010
• Start date: November 2005
• Est. completion date: October 2007

Study information

• Verified date: September 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Drug:
• Pexacerfont
Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
• Escitalopram
Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
• Placebo
Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Locations

Country	Name	City	State
United States	Albuquerque Neuroscience, Inc.	Albuquerque	New Mexico
United States	Emory University	Atlanta	Georgia
United States	Futuresearch Trials	Austin	Texas
United States	Claghorn-Lesem Research Clinic	Bellaire	Texas
United States	Northwest Clinical Research Center	Bellevue	Washington
United States	Social Psychiatry Research Institute	Brooklyn	New York
United States	Northbrooke Research Center	Brown Deer	Wisconsin
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	University Of North Carolina At Chapel Hill	Chapel Hill	North Carolina
United States	Psychiatric Alliance Of The Blue Ridge	Charlottesville	Virginia
United States	Community Research	Cincinnati	Ohio
United States	Usc School Of Medicine	Columbia	South Carolina
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Insite Clinical Research	Desoto	Texas
United States	Cunningham Clinical Research, Llc	Edwardsville	Illinois
United States	University Of Connecticut Health Center	Farmington	Connecticut
United States	Summit Research Network	Farmington Hills	Michigan
United States	University Of Florida	Gainesville	Florida
United States	Alexian Center For Psychiatric Research	Hoffman Estates	Illinois
United States	Clinical Neuroscience Solutions, Inc.	Jacksonville	Florida
United States	Alpine Clinic	Lafayette	Indiana
United States	R/D Clinical Research, Inc.	Lake Jackson	Texas
United States	Suburban Research Associates	Media	Pennsylvania
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Dean Foundation For Health Research & Education	Middleton	Wisconsin
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Bioscience Research, Llc	New York	New York
United States	Social Psychiatry Research Institute	New York	New York
United States	American Medical Research, Inc.	Oakbrook	Illinois
United States	Pacific Clinical Research Medical Group	Orange	California
United States	Clinical Neuroscience Solutions, Inc.	Orlando	Florida
United States	Oregon Center For Clinical Investigations, Inc. (Occi, Inc)	Portland	Oregon
United States	Summit Research Network	Portland	Oregon
United States	Richard H. Weisler, Md	Raleigh	North Carolina
United States	Dupont Clinical Research	Rockville	Maryland
United States	Radiant Research, Salt Lake City	Salt Lake City	Utah
United States	University Of Utah School Of Medicine	Salt Lake City	Utah
United States	Croft, Harry A.	San Antonio	Texas
United States	Summit Research Network (Seattle), Inc.	Seattle	Washington
United States	J. Gary Booker, Md	Shreveport	Louisiana
United States	Apc Clinical Research Trials Nw, Pa	Springdale	Arkansas
United States	Regions Hospital	St. Paul	Minnesota
United States	Behavioral Medical Research Of Staten Island	Staten Island	New York
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Front Range Clinical Research	Wheatridge	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)		Week 8	No
Secondary	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	Yes
Secondary	Compare efficacy of escitalopram to placebo		at endpoint and at each visit	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm