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

NCT ID: NCT00135421

Last Updated: 2010-03-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

Pexacerfont

Intervention Type DRUG

Tablets \& Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation

A2

Group Type ACTIVE_COMPARATOR

Escitalopram

Intervention Type DRUG

Tablets \& Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

A3

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Tablets \& Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Interventions

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Pexacerfont

Tablets \& Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation

Intervention Type DRUG

Escitalopram

Tablets \& Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Intervention Type DRUG

Placebo

Tablets \& Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.

Intervention Type DRUG

Other Intervention Names

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BMS-562086

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Apc Clinical Research Trials Nw, Pa

Springdale, Arkansas, United States

Site Status

Pacific Clinical Research Medical Group

Orange, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

Site Status

Front Range Clinical Research

Wheat Ridge, Colorado, United States

Site Status

University Of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

University Of Florida

Gainesville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Cunningham Clinical Research, Llc

Edwardsville, Illinois, United States

Site Status

Alexian Center For Psychiatric Research

Hoffman Estates, Illinois, United States

Site Status

American Medical Research, Inc.

Oak Brook, Illinois, United States

Site Status

Alpine Clinic

Lafayette, Indiana, United States

Site Status

J. Gary Booker, Md

Shreveport, Louisiana, United States

Site Status

Dupont Clinical Research

Rockville, Maryland, United States

Site Status

Summit Research Network

Farmington Hills, Michigan, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Albuquerque Neuroscience, Inc.

Albuquerque, New Mexico, United States

Site Status

Social Psychiatry Research Institute

Brooklyn, New York, United States

Site Status

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Site Status

Bioscience Research, Llc

New York, New York, United States

Site Status

Social Psychiatry Research Institute

New York, New York, United States

Site Status

Behavioral Medical Research Of Staten Island

Staten Island, New York, United States

Site Status

University Of North Carolina At Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Richard H. Weisler, Md

Raleigh, North Carolina, United States

Site Status

Community Research

Cincinnati, Ohio, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

Portland, Oregon, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

Suburban Research Associates

Media, Pennsylvania, United States

Site Status

Usc School Of Medicine

Columbia, South Carolina, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Futuresearch Trials

Austin, Texas, United States

Site Status

Claghorn-Lesem Research Clinic

Bellaire, Texas, United States

Site Status

Insite Clinical Research

DeSoto, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

Croft, Harry A.

San Antonio, Texas, United States

Site Status

Radiant Research, Salt Lake City

Salt Lake City, Utah, United States

Site Status

University Of Utah School Of Medicine

Salt Lake City, Utah, United States

Site Status

Psychiatric Alliance Of The Blue Ridge

Charlottesville, Virginia, United States

Site Status

Dominion Clinical Research

Midlothian, Virginia, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Summit Research Network (Seattle), Inc.

Seattle, Washington, United States

Site Status

Northbrooke Research Center

Brown Deer, Wisconsin, United States

Site Status

Dean Foundation For Health Research & Education

Middleton, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CN148-007

Identifier Type: -

Identifier Source: org_study_id

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