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Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Phase 2
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 Generalized Anxiety Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Outpatient women ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02)

Exclusion Criteria:

  • Males
  • Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years

Sites / Locations

  • Pivotal Research Centers
  • Pacific Clinical Research Medical Group
  • Us Clinical Research Centers, Llc
  • Pacific Institute For Medical Research, Inc.
  • Affiliated Research Institute
  • Pacific Clinical Research Medical Group
  • Radiant Research, Inc.
  • University Of Connecticut Health Center
  • Comprehensive Psychiatric Care, Pc
  • Meridien Research
  • Clinical Neuroscience Solutions
  • Comprehensive Neuroscience, Inc.
  • Stedman Clinical Trials
  • Janus Center For Psychiatric Research
  • Carman Research
  • Indiana University School Of Medicine
  • Alpine Clinic
  • Cientifica, Inc. At Prairie View Inc.
  • Ctt, Inc.
  • J. Gary Booker, Md, Apmc
  • Pharmasite Research, Inc.
  • Capital Clinical Research Associates
  • Boston Clinical Trials, Inc.
  • Regions Hospital
  • Neurobehavioral Research, Inc.
  • Bioscience Research, Llc
  • Fieve Clinical Services, Inc.
  • Social Psychiatry Research Institute
  • Behavioral Medical Research Of Staten Island
  • Richmond Behavioral Associates
  • North Carolina Neuropsychiatry, Pa
  • Medark Clinical Research
  • Psychiatry And Clinical Research
  • Community Research
  • Midwest Clinical Research Center
  • Ips Research Company
  • University Of Oklahoma Health Sciences Center
  • Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
  • Lehigh Valley Hospital
  • Rhode Island Mood & Memory Research Institute
  • Medical University Of South Carolina
  • Carolina Clinical Research Services, Llc
  • Avera Research Institute
  • Clinical Neuroscience Solutions, Inc.
  • Futuresearch Trials
  • Futuresearch Trials Of Dallas
  • Claghorn-Lesem Research Clinic
  • Medlabs Research Of Houston, Inc.
  • Red Oak Psychiatry Associates, Pa
  • Dominion Clinical Research
  • 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 Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)

Secondary Outcome Measures

Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score

Full Information

First Posted
May 31, 2007
Last Updated
September 23, 2015
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT00481325
Brief Title
Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Official Title
A Multicenter, Randomized, Double-Blind, Placebo and Escitalopram Controlled Trial of the Safety and Efficacy of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (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 study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
260 (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, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
Intervention Type
Drug
Intervention Name(s)
escitalopram
Intervention Description
Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Primary Outcome Measure Information:
Title
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Time Frame
Week 8
Title
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Time Frame
Week 8

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 ages 18-65 meeting Diagnostic and Statistical Manual of Mental Disorders Manual, Fourth Edition, Text Revision (DSM-IV TR) criteria for Generalized Anxiety Disorder (GAD), either moderate or severe (300.02) Exclusion Criteria: Males Patients who report a history of inadequate response to three or more adequate trials of any selective Serotonin reuptake inhibitors (SSRIs) for GAD within the last three years
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
Pivotal Research Centers
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Us Clinical Research Centers, Llc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92627
Country
United States
Facility Name
Pacific Institute For Medical Research, Inc.
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Radiant Research, Inc.
City
Denver
State/Province
Colorado
ZIP/Postal Code
80212
Country
United States
Facility Name
University Of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030
Country
United States
Facility Name
Comprehensive Psychiatric Care, Pc
City
Norwich
State/Province
Connecticut
ZIP/Postal Code
06360
Country
United States
Facility Name
Meridien Research
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Comprehensive Neuroscience, Inc.
City
St Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
Stedman Clinical Trials
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Janus Center For Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Carman Research
City
Smyrna
State/Province
Georgia
ZIP/Postal Code
30080
Country
United States
Facility Name
Indiana University School Of Medicine
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Alpine Clinic
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47905
Country
United States
Facility Name
Cientifica, Inc. At Prairie View Inc.
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Ctt, Inc.
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
66206
Country
United States
Facility Name
J. Gary Booker, Md, Apmc
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71104
Country
United States
Facility Name
Pharmasite Research, Inc.
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Capital Clinical Research Associates
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Boston Clinical Trials, Inc.
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Regions Hospital
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55101
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
Fieve Clinical Services, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10021
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
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
North Carolina Neuropsychiatry, Pa
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Medark Clinical Research
City
Morganton
State/Province
North Carolina
ZIP/Postal Code
28655
Country
United States
Facility Name
Psychiatry And Clinical Research
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
Ips Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
University Of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
Lehigh Valley Hospital
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Rhode Island Mood & Memory Research Institute
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Medical University Of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Carolina Clinical Research Services, Llc
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29201
Country
United States
Facility Name
Avera Research Institute
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
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
Futuresearch Trials Of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Claghorn-Lesem Research Clinic
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Medlabs Research Of Houston, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77057
Country
United States
Facility Name
Red Oak Psychiatry Associates, Pa
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Dominion Clinical Research
City
Midlothian
State/Province
Virginia
ZIP/Postal Code
23112
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

Citations:
PubMed Identifier
20455246
Citation
Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang SP, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double-blind, active comparator and placebo-controlled trial of a corticotropin-releasing factor receptor-1 antagonist in generalized anxiety disorder. Depress Anxiety. 2010 May;27(5):417-25. doi: 10.1002/da.20695.
Results Reference
derived

Learn more about this trial

Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder

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