Clinical trial NCT00135421: Study of BMS-562086 in the Treatment of Outpatients With Major Depressive Disorder
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2005-08-26
Enrollment: 271
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
timeFrame: Week 8
Secondary outcomes:
measure: Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
timeFrame: every visit and endpoint
measure: Compare efficacy of escitalopram to placebo
timeFrame: at endpoint and at each visit
Other outcomes:
Locations:
city: Springdale
country: United States
facility: Apc Clinical Research Trials Nw, Pa
state: Arkansas
city: Orange
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Wheatridge
country: United States
facility: Front Range Clinical Research
state: Colorado
city: Farmington
country: United States
facility: University Of Connecticut Health Center
state: Connecticut
city: Gainesville
country: United States
facility: University Of Florida
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Orlando
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Edwardsville
country: United States
facility: Cunningham Clinical Research, Llc
state: Illinois
city: Hoffman Estates
country: United States
facility: Alexian Center For Psychiatric Research
state: Illinois
city: Oakbrook
country: United States
facility: American Medical Research, Inc.
state: Illinois
city: Lafayette
country: United States
facility: Alpine Clinic
state: Indiana
city: Shreveport
country: United States
facility: J. Gary Booker, Md
state: Louisiana
city: Rockville
country: United States
facility: Dupont Clinical Research
state: Maryland
city: Farmington Hills
country: United States
facility: Summit Research Network
state: Michigan
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Albuquerque
country: United States
facility: Albuquerque Neuroscience, Inc.
state: New Mexico
city: Brooklyn
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Bioscience Research, Llc
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research Of Staten Island
state: New York
city: Chapel Hill
country: United States
facility: University Of North Carolina At Chapel Hill
state: North Carolina
city: Raleigh
country: United States
facility: Richard H. Weisler, Md
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Portland
country: United States
facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
state: Oregon
city: Portland
country: United States
facility: Summit Research Network
state: Oregon
city: Media
country: United States
facility: Suburban Research Associates
state: Pennsylvania
city: Columbia
country: United States
facility: Usc School Of Medicine
state: South Carolina
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Futuresearch Trials
state: Texas
city: Bellaire
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Desoto
country: United States
facility: Insite Clinical Research
state: Texas
city: Lake Jackson
country: United States
facility: R/D Clinical Research, Inc.
state: Texas
city: San Antonio
country: United States
facility: Croft, Harry A.
state: Texas
city: Salt Lake City
country: United States
facility: Radiant Research, Salt Lake City
state: Utah
city: Salt Lake City
country: United States
facility: University Of Utah School Of Medicine
state: Utah
city: Charlottesville
country: United States
facility: Psychiatric Alliance Of The Blue Ridge
state: Virginia
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: Summit Research Network (Seattle), Inc.
state: Washington
city: Brown Deer
country: United States
facility: Northbrooke Research Center
state: Wisconsin
city: Middleton
country: United States
facility: Dean Foundation For Health Research & Education
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: