Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
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
1 other identifier
interventional
271
1 country
45
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 major-depressive-disorder
Started Nov 2005
Typical duration for phase_1 major-depressive-disorder
45 active sites
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
First Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 26, 2005
CompletedStudy Start
First participant enrolled
November 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedMarch 2, 2010
September 1, 2008
1.9 years
August 25, 2005
February 27, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Week 8
Secondary Outcomes (2)
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
Study Arms (3)
A1
EXPERIMENTALA2
ACTIVE COMPARATORA3
PLACEBO COMPARATORInterventions
Tablets \& Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
Tablets \& Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Tablets \& Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Males
- Patients with treatment resistance to other antidepressants
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (45)
Apc Clinical Research Trials Nw, Pa
Springdale, Arkansas, 72762, United States
Pacific Clinical Research Medical Group
Orange, California, 92868, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Front Range Clinical Research
Wheat Ridge, Colorado, 80033, United States
University Of Connecticut Health Center
Farmington, Connecticut, 06030, United States
University Of Florida
Gainesville, Florida, 32606, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Emory University
Atlanta, Georgia, 30329, United States
Cunningham Clinical Research, Llc
Edwardsville, Illinois, 62025, United States
Alexian Center For Psychiatric Research
Hoffman Estates, Illinois, 60169, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Alpine Clinic
Lafayette, Indiana, 47905, United States
J. Gary Booker, Md
Shreveport, Louisiana, 71104, United States
Dupont Clinical Research
Rockville, Maryland, 20852, United States
Summit Research Network
Farmington Hills, Michigan, 48336, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, 87102, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Bioscience Research, Llc
New York, New York, 10016, United States
Social Psychiatry Research Institute
New York, New York, 10021, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305, United States
University Of North Carolina At Chapel Hill
Chapel Hill, North Carolina, 27599, United States
Richard H. Weisler, Md
Raleigh, North Carolina, 27609, United States
Community Research
Cincinnati, Ohio, 45227, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Portland, Oregon, 97210, United States
Summit Research Network
Portland, Oregon, 97210, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
Usc School Of Medicine
Columbia, South Carolina, 29203, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Futuresearch Trials
Austin, Texas, 78756, United States
Claghorn-Lesem Research Clinic
Bellaire, Texas, 77401, United States
Insite Clinical Research
DeSoto, Texas, 75115, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Croft, Harry A.
San Antonio, Texas, 78229, United States
Radiant Research, Salt Lake City
Salt Lake City, Utah, 84107, United States
University Of Utah School Of Medicine
Salt Lake City, Utah, 84132, United States
Psychiatric Alliance Of The Blue Ridge
Charlottesville, Virginia, 22905, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
Summit Research Network (Seattle), Inc.
Seattle, Washington, 98104, United States
Northbrooke Research Center
Brown Deer, Wisconsin, 53223, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 26, 2005
Study Start
November 1, 2005
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
March 2, 2010
Record last verified: 2008-09