Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
NCT ID: NCT00481325
Last Updated: 2015-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
260 participants
INTERVENTIONAL
2007-07-31
2008-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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A1
pexacerfont
Tablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
A2
escitalopram
Tablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
A3
placebo
Tablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Interventions
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pexacerfont
Tablets \& Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
escitalopram
Tablets \& Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
placebo
Tablets \& Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
65 Years
FEMALE
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Bristol-Myers Squibb
Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Pivotal Research Centers
Mesa, Arizona, United States
Pacific Clinical Research Medical Group
Burbank, California, United States
Us Clinical Research Centers, Llc
Costa Mesa, California, United States
Pacific Institute For Medical Research, Inc.
Los Angeles, California, United States
Affiliated Research Institute
San Diego, California, United States
Pacific Clinical Research Medical Group
Upland, California, United States
Radiant Research, Inc.
Denver, Colorado, 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
Stedman Clinical Trials
Tampa, Florida, United States
Janus Center For Psychiatric Research
West Palm Beach, Florida, United States
Carman Research
Smyrna, Georgia, United States
Indiana University School Of Medicine
Indianapolis, Indiana, United States
Alpine Clinic
Lafayette, Indiana, United States
Cientifica, Inc. At Prairie View Inc.
Newton, Kansas, 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
Saint 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
Richmond Behavioral Associates
Staten Island, New York, United States
North Carolina Neuropsychiatry, Pa
Charlotte, North Carolina, United States
Medark Clinical Research
Morganton, North Carolina, United States
Psychiatry And Clinical Research
Raleigh, North Carolina, United States
Community Research
Cincinnati, Ohio, United States
Midwest Clinical Research Center
Dayton, Ohio, United States
Ips Research Company
Oklahoma City, Oklahoma, United States
University Of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
Salem, Oregon, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Medical University Of South Carolina
Charleston, South Carolina, United States
Carolina Clinical Research Services, Llc
Columbia, South Carolina, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Futuresearch Trials
Austin, Texas, United States
Futuresearch Trials Of Dallas
Dallas, Texas, United States
Claghorn-Lesem Research Clinic
Houston, Texas, United States
Medlabs Research Of Houston, Inc.
Houston, Texas, United States
Red Oak Psychiatry Associates, Pa
Houston, Texas, United States
Dominion Clinical Research
Midlothian, Virginia, United States
Dean Foundation For Health Research & Education
Middleton, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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CN148-015
Identifier Type: -
Identifier Source: org_study_id
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