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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Pexacerfont
Escitalopram
Placebo
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Apc Clinical Research Trials Nw, Pa
  • Pacific Clinical Research Medical Group
  • Pacific Clinical Research Medical Group
  • Front Range Clinical Research
  • University Of Connecticut Health Center
  • University Of Florida
  • Clinical Neuroscience Solutions, Inc.
  • Clinical Neuroscience Solutions, Inc.
  • Emory University
  • Cunningham Clinical Research, Llc
  • Alexian Center For Psychiatric Research
  • American Medical Research, Inc.
  • Alpine Clinic
  • J. Gary Booker, Md
  • Dupont Clinical Research
  • Summit Research Network
  • Regions Hospital
  • Albuquerque Neuroscience, Inc.
  • Social Psychiatry Research Institute
  • Neurobehavioral Research, Inc.
  • Bioscience Research, Llc
  • Social Psychiatry Research Institute
  • Behavioral Medical Research Of Staten Island
  • University Of North Carolina At Chapel Hill
  • Richard H. Weisler, Md
  • Community Research
  • Midwest Clinical Research Center
  • Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
  • Summit Research Network
  • Suburban Research Associates
  • Usc School Of Medicine
  • Clinical Neuroscience Solutions, Inc.
  • Futuresearch Trials
  • Claghorn-Lesem Research Clinic
  • Insite Clinical Research
  • R/D Clinical Research, Inc.
  • Croft, Harry A.
  • Radiant Research, Salt Lake City
  • University Of Utah School Of Medicine
  • Psychiatric Alliance Of The Blue Ridge
  • Dominion Clinical Research
  • Northwest Clinical Research Center
  • Summit Research Network (Seattle), Inc.
  • Northbrooke Research Center
  • Dean Foundation For Health Research & Education

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

A1

A2

A3

Arm Description

Outcomes

Primary Outcome Measures

Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)

Secondary Outcome Measures

Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
Compare efficacy of escitalopram to placebo

Full Information

First Posted
August 25, 2005
Last Updated
February 27, 2010
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00135421
Brief Title
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

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A1
Arm Type
Experimental
Arm Title
A2
Arm Type
Active Comparator
Arm Title
A3
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Pexacerfont
Other Intervention Name(s)
BMS-562086
Intervention Description
Tablets & Capsules, Oral, 100 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Intervention Description
Tablets & Capsules, Oral, 20 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablets & Capsules, Oral, 0 mg, Once daily, Up to 8 weeks followed by 8 weeks of observation.
Primary Outcome Measure Information:
Title
Mean change from baseline to endpoint (Week 8) on the total score of the Hamilton Depression Rating Scale (HAMD-17)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Compare safety and tolerability of BMS-562086 to placebo by assessing adverse events, vital signs, electrocardiograms (ECGs), physical examinations and clinical lab tests
Time Frame
every visit and endpoint
Title
Compare efficacy of escitalopram to placebo
Time Frame
at endpoint and at each visit

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Apc Clinical Research Trials Nw, Pa
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72762
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Front Range Clinical Research
City
Wheatridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
University Of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
University Of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32606
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
Cunningham Clinical Research, Llc
City
Edwardsville
State/Province
Illinois
ZIP/Postal Code
62025
Country
United States
Facility Name
Alexian Center For Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
American Medical Research, Inc.
City
Oakbrook
State/Province
Illinois
ZIP/Postal Code
60523
Country
United States
Facility Name
Alpine Clinic
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
J. Gary Booker, Md
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Dupont Clinical Research
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Summit Research Network
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Facility Name
Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
Albuquerque Neuroscience, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Social Psychiatry Research Institute
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Bioscience Research, Llc
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Social Psychiatry Research Institute
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Behavioral Medical Research Of Staten Island
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
University Of North Carolina At Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Richard H. Weisler, Md
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Community Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Midwest Clinical Research Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45408
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Summit Research Network
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
Usc School Of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Futuresearch Trials
City
Austin
State/Province
Texas
ZIP/Postal Code
78756
Country
United States
Facility Name
Claghorn-Lesem Research Clinic
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Insite Clinical Research
City
Desoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
R/D Clinical Research, Inc.
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Croft, Harry A.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Radiant Research, Salt Lake City
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University Of Utah School Of Medicine
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Psychiatric Alliance Of The Blue Ridge
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22905
Country
United States
Facility Name
Dominion Clinical Research
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
Summit Research Network (Seattle), Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Northbrooke Research Center
City
Brown Deer
State/Province
Wisconsin
ZIP/Postal Code
53223
Country
United States
Facility Name
Dean Foundation For Health Research & Education
City
Middleton
State/Province
Wisconsin
ZIP/Postal Code
53562
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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