Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
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
1 other identifier
interventional
260
1 country
51
Brief Summary
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2007
Shorter than P25 for phase_2
51 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 31, 2007
CompletedFirst Posted
Study publicly available on registry
June 1, 2007
CompletedStudy Start
First participant enrolled
July 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2008
CompletedOctober 12, 2015
September 1, 2015
8 months
May 31, 2007
September 23, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
Week 8
Secondary Outcomes (2)
Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
Week 8
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
Week 8
Study Arms (3)
A1
EXPERIMENTALA2
ACTIVE COMPARATORA3
PLACEBO COMPARATORInterventions
Tablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (51)
Pivotal Research Centers
Mesa, Arizona, 85210, United States
Pacific Clinical Research Medical Group
Burbank, California, 91505, United States
Us Clinical Research Centers, Llc
Costa Mesa, California, 92627, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, 90024, United States
Affiliated Research Institute
San Diego, California, 92108, United States
Pacific Clinical Research Medical Group
Upland, California, 91786, United States
Radiant Research, Inc.
Denver, Colorado, 80212, United States
University Of Connecticut Health Center
Farmington, Connecticut, 06030, United States
Comprehensive Psychiatric Care, Pc
Norwich, Connecticut, 06360, United States
Meridien Research
Brooksville, Florida, 34613, United States
Clinical Neuroscience Solutions
Jacksonville, Florida, 32216, United States
Comprehensive Neuroscience, Inc.
St. Petersburg, Florida, 33702, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, 33407, United States
Carman Research
Smyrna, Georgia, 30080, United States
Indiana University School Of Medicine
Indianapolis, Indiana, 46202, United States
Alpine Clinic
Lafayette, Indiana, 47905, United States
Cientifica, Inc. At Prairie View Inc.
Newton, Kansas, 67114, United States
Ctt, Inc.
Prairie Village, Kansas, 66206, United States
J. Gary Booker, Md, Apmc
Shreveport, Louisiana, 71104, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
Capital Clinical Research Associates
Rockville, Maryland, 20852, United States
Boston Clinical Trials, Inc.
Boston, Massachusetts, 02135, United States
Regions Hospital
Saint Paul, Minnesota, 55101, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516, United States
Bioscience Research, Llc
New York, New York, 10016, United States
Fieve Clinical Services, Inc.
New York, New York, 10021, United States
Social Psychiatry Research Institute
New York, New York, 10021, United States
Behavioral Medical Research Of Staten Island
Staten Island, New York, 10305, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
North Carolina Neuropsychiatry, Pa
Charlotte, North Carolina, 28209, United States
Medark Clinical Research
Morganton, North Carolina, 28655, United States
Psychiatry And Clinical Research
Raleigh, North Carolina, 27609, United States
Community Research
Cincinnati, Ohio, 45227, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Ips Research Company
Oklahoma City, Oklahoma, 73103, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Salem, Oregon, 97301, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Medical University Of South Carolina
Charleston, South Carolina, 29406, United States
Carolina Clinical Research Services, Llc
Columbia, South Carolina, 29201, United States
Avera Research Institute
Sioux Falls, South Dakota, 57105, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Futuresearch Trials
Austin, Texas, 78756, United States
Futuresearch Trials Of Dallas
Dallas, Texas, 75231, United States
Claghorn-Lesem Research Clinic
Houston, Texas, 77008, United States
Medlabs Research Of Houston, Inc.
Houston, Texas, 77057, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, 77090, United States
Dominion Clinical Research
Midlothian, Virginia, 23112, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, 53562, United States
Related Publications (1)
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.
PMID: 20455246DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bristol-Myers Squibb
Bristol-Myers Squibb
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 31, 2007
First Posted
June 1, 2007
Study Start
July 1, 2007
Primary Completion
March 1, 2008
Study Completion
March 1, 2008
Last Updated
October 12, 2015
Record last verified: 2015-09