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

September 23, 2015 updated by: Bristol-Myers Squibb

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

The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

260

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotal Research Centers
    • California
      • Burbank, California, United States, 91505
        • Pacific Clinical Research Medical Group
      • Costa Mesa, California, United States, 92627
        • Us Clinical Research Centers, Llc
      • Los Angeles, California, United States, 90024
        • Pacific Institute For Medical Research, Inc.
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • Upland, California, United States, 91786
        • Pacific Clinical Research Medical Group
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research, Inc.
    • Connecticut
      • Farmington, Connecticut, United States, 06030
        • University of Connecticut Health Center
      • Norwich, Connecticut, United States, 06360
        • Comprehensive Psychiatric Care, Pc
    • Florida
      • Brooksville, Florida, United States, 34613
        • Meridien Research
      • Jacksonville, Florida, United States, 32216
        • Clinical Neuroscience Solutions
      • St Petersburg, Florida, United States, 33702
        • Comprehensive NeuroScience, Inc.
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Smyrna, Georgia, United States, 30080
        • Carman Research
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
      • Lafayette, Indiana, United States, 47905
        • Alpine Clinic
    • Kansas
      • Newton, Kansas, United States, 67114
        • Cientifica, Inc. At Prairie View Inc.
      • Prairie Village, Kansas, United States, 66206
        • Ctt, Inc.
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • J. Gary Booker, MD, APMC
    • Maryland
      • Baltimore, Maryland, United States, 21208
        • Pharmasite Research, Inc.
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Associates
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials, Inc.
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital
    • New York
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10021
        • Social Psychiatry Research Institute
      • New York, New York, United States, 10021
        • Fieve Clinical Services, Inc.
      • New York, New York, United States, 10016
        • Bioscience Research, LLC
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research Of Staten Island
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • North Carolina Neuropsychiatry, PA
      • Morganton, North Carolina, United States, 28655
        • Medark Clinical Research
      • Raleigh, North Carolina, United States, 27609
        • Psychiatry And Clinical Research
    • Ohio
      • Cincinnati, Ohio, United States, 45227
        • Community Research
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research Company
    • Oregon
      • Salem, Oregon, United States, 97301
        • Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • LeHigh Valley Hospital
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Rhode Island Mood & Memory Research Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina
      • Columbia, South Carolina, United States, 29201
        • Carolina Clinical Research Services, Llc
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Research Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
    • Texas
      • Austin, Texas, United States, 78756
        • FutureSearch Trials
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • Houston, Texas, United States, 77090
        • Red Oak Psychiatry Associates, PA
      • Houston, Texas, United States, 77008
        • Claghorn-Lesem Research Clinic
      • Houston, Texas, United States, 77057
        • Medlabs Research Of Houston, Inc.
    • Virginia
      • Midlothian, Virginia, United States, 23112
        • Dominion Clinical Research
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation For Health Research & Education

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A2
Drug: escitalopram
Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
Experimental: A1
Drug: pexacerfont
Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
Other Names:
  • (BMS-562086)
Placebo Comparator: A3
Drug: placebo
Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Time Frame: Week 8
Week 8

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

March 1, 2008

Study Registration Dates

First Submitted

May 31, 2007

First Submitted That Met QC Criteria

May 31, 2007

First Posted (Estimate)

June 1, 2007

Study Record Updates

Last Update Posted (Estimate)

October 12, 2015

Last Update Submitted That Met QC Criteria

September 23, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CN148-015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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