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
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 |
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.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
Bristol-Myers Squibb |
United States,
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 |
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