Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
- Conditions
- Major Depressive Disorder
- Interventions
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 271
- 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.
- 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)
Emory University
🇺🇸Atlanta, Georgia, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
University Of North Carolina At Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Cunningham Clinical Research, Llc
🇺🇸Edwardsville, Illinois, United States
Alpine Clinic
🇺🇸Lafayette, Indiana, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
American Medical Research, Inc.
🇺🇸Oakbrook, Illinois, United States
University Of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Alexian Center For Psychiatric Research
🇺🇸Hoffman Estates, Illinois, United States
Apc Clinical Research Trials Nw, Pa
🇺🇸Springdale, Arkansas, United States
Dupont Clinical Research
🇺🇸Rockville, Maryland, United States
Front Range Clinical Research
🇺🇸Wheatridge, Colorado, United States
Regions Hospital
🇺🇸St. Paul, Minnesota, United States
Summit Research Network
🇺🇸Portland, Oregon, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
🇺🇸Portland, Oregon, United States
Croft, Harry A.
🇺🇸San Antonio, Texas, 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
Summit Research Network (Seattle), Inc.
🇺🇸Seattle, Washington, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
University Of Florida
🇺🇸Gainesville, Florida, United States
Social Psychiatry Research Institute
🇺🇸New York, New York, United States
J. Gary Booker, Md
🇺🇸Shreveport, Louisiana, United States
Behavioral Medical Research Of Staten Island
🇺🇸Staten Island, New York, United States
Richard H. Weisler, Md
🇺🇸Raleigh, North Carolina, United States
Bioscience Research, Llc
🇺🇸New York, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Usc School Of Medicine
🇺🇸Columbia, South Carolina, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
Futuresearch Trials
🇺🇸Austin, Texas, United States
Claghorn-Lesem Research Clinic
🇺🇸Bellaire, Texas, United States
Insite Clinical Research
🇺🇸Desoto, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Psychiatric Alliance Of The Blue Ridge
🇺🇸Charlottesville, Virginia, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States
Northbrooke Research Center
🇺🇸Brown Deer, Wisconsin, United States