Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Interventions
- Registration Number
- NCT00481325
- Lead Sponsor
- Bristol-Myers Squibb
- Brief Summary
The purpose of this study is to learn about the safety and efficacy of pexacerfont in outpatients diagnosed with Generalized Anxiety Disorder
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 260
- 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)
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A1 pexacerfont - A3 placebo - A2 escitalopram -
- Primary Outcome Measures
Name Time Method Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) Week 8
- Secondary Outcome Measures
Name Time Method Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score Week 8 Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score Week 8
Trial Locations
- Locations (50)
Us Clinical Research Centers, Llc
🇺🇸Costa Mesa, California, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Pivotal Research Centers
🇺🇸Mesa, Arizona, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
Pacific Institute For Medical Research, Inc.
🇺🇸Los Angeles, California, United States
University Of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Comprehensive Psychiatric Care, Pc
🇺🇸Norwich, Connecticut, United States
Meridien Research
🇺🇸Brooksville, Florida, United States
Clinical Neuroscience Solutions
🇺🇸Jacksonville, Florida, United States
Comprehensive Neuroscience, Inc.
🇺🇸St Petersburg, Florida, United States
Janus Center For Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Carman Research
🇺🇸Smyrna, Georgia, United States
Alpine Clinic
🇺🇸Lafayette, Indiana, United States
Ctt, Inc.
🇺🇸Prairie Village, Kansas, United States
J. Gary Booker, Md, Apmc
🇺🇸Shreveport, Louisiana, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Capital Clinical Research Associates
🇺🇸Rockville, Maryland, United States
Boston Clinical Trials, Inc.
🇺🇸Boston, Massachusetts, United States
Regions Hospital
🇺🇸St. Paul, Minnesota, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
Bioscience Research, Llc
🇺🇸New York, New York, United States
Fieve Clinical Services, Inc.
🇺🇸New York, New York, United States
Social Psychiatry Research Institute
🇺🇸New York, New York, United States
Behavioral Medical Research Of Staten Island
🇺🇸Staten Island, New York, United States
North Carolina Neuropsychiatry, Pa
🇺🇸Charlotte, North Carolina, United States
Richmond Behavioral Associates
🇺🇸Staten Island, New York, United States
Medark Clinical Research
🇺🇸Morganton, North Carolina, United States
Psychiatry And Clinical Research
🇺🇸Raleigh, North Carolina, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
🇺🇸Salem, Oregon, United States
Rhode Island Mood & Memory Research Institute
🇺🇸East Providence, Rhode Island, United States
Medical University Of South Carolina
🇺🇸Charleston, South Carolina, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
Carolina Clinical Research Services, Llc
🇺🇸Columbia, South Carolina, United States
Futuresearch Trials
🇺🇸Austin, Texas, United States
Futuresearch Trials Of Dallas
🇺🇸Dallas, Texas, United States
Claghorn-Lesem Research Clinic
🇺🇸Houston, Texas, United States
Dean Foundation For Health Research & Education
🇺🇸Middleton, Wisconsin, United States
Dominion Clinical Research
🇺🇸Midlothian, Virginia, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Indiana University School Of Medicine
🇺🇸Indianapolis, Indiana, United States
Community Research
🇺🇸Cincinnati, Ohio, United States
Medlabs Research Of Houston, Inc.
🇺🇸Houston, Texas, United States
Red Oak Psychiatry Associates, Pa
🇺🇸Houston, Texas, United States
Cientifica, Inc. At Prairie View Inc.
🇺🇸Newton, Kansas, United States
Ips Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Radiant Research, Inc.
🇺🇸Denver, Colorado, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
University Of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Avera Research Institute
🇺🇸Sioux Falls, South Dakota, United States