Clinical trial NCT00481325: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Generalized Anxiety Disorder
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-06-01
Enrollment: 260
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)
timeFrame: Week 8
Secondary outcomes:
measure: Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score
timeFrame: Week 8
measure: Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score
timeFrame: Week 8
Other outcomes:
Locations:
city: Mesa
country: United States
facility: Pivotal Research Centers
state: Arizona
city: Burbank
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Costa Mesa
country: United States
facility: Us Clinical Research Centers, Llc
state: California
city: Los Angeles
country: United States
facility: Pacific Institute For Medical Research, Inc.
state: California
city: San Diego
country: United States
facility: Affiliated Research Institute
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Medical Group
state: California
city: Denver
country: United States
facility: Radiant Research, Inc.
state: Colorado
city: Farmington
country: United States
facility: University Of Connecticut Health Center
state: Connecticut
city: Norwich
country: United States
facility: Comprehensive Psychiatric Care, Pc
state: Connecticut
city: Brooksville
country: United States
facility: Meridien Research
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions
state: Florida
city: St Petersburg
country: United States
facility: Comprehensive Neuroscience, Inc.
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials
state: Florida
city: West Palm Beach
country: United States
facility: Janus Center For Psychiatric Research
state: Florida
city: Smyrna
country: United States
facility: Carman Research
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University School Of Medicine
state: Indiana
city: Lafayette
country: United States
facility: Alpine Clinic
state: Indiana
city: Newton
country: United States
facility: Cientifica, Inc. At Prairie View Inc.
state: Kansas
city: Prairie Village
country: United States
facility: Ctt, Inc.
state: Kansas
city: Shreveport
country: United States
facility: J. Gary Booker, Md, Apmc
state: Louisiana
city: Baltimore
country: United States
facility: Pharmasite Research, Inc.
state: Maryland
city: Rockville
country: United States
facility: Capital Clinical Research Associates
state: Maryland
city: Boston
country: United States
facility: Boston Clinical Trials, Inc.
state: Massachusetts
city: St. Paul
country: United States
facility: Regions Hospital
state: Minnesota
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: New York
country: United States
facility: Bioscience Research, Llc
state: New York
city: New York
country: United States
facility: Fieve Clinical Services, Inc.
state: New York
city: New York
country: United States
facility: Social Psychiatry Research Institute
state: New York
city: Staten Island
country: United States
facility: Behavioral Medical Research Of Staten Island
state: New York
city: Staten Island
country: United States
facility: Richmond Behavioral Associates
state: New York
city: Charlotte
country: United States
facility: North Carolina Neuropsychiatry, Pa
state: North Carolina
city: Morganton
country: United States
facility: Medark Clinical Research
state: North Carolina
city: Raleigh
country: United States
facility: Psychiatry And Clinical Research
state: North Carolina
city: Cincinnati
country: United States
facility: Community Research
state: Ohio
city: Dayton
country: United States
facility: Midwest Clinical Research Center
state: Ohio
city: Oklahoma City
country: United States
facility: Ips Research Company
state: Oklahoma
city: Oklahoma City
country: United States
facility: University Of Oklahoma Health Sciences Center
state: Oklahoma
city: Salem
country: United States
facility: Oregon Center For Clinical Investigations, Inc. (Occi, Inc)
state: Oregon
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Charleston
country: United States
facility: Medical University Of South Carolina
state: South Carolina
city: Columbia
country: United States
facility: Carolina Clinical Research Services, Llc
state: South Carolina
city: Sioux Falls
country: United States
facility: Avera Research Institute
state: South Dakota
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions, Inc.
state: Tennessee
city: Austin
country: United States
facility: Futuresearch Trials
state: Texas
city: Dallas
country: United States
facility: Futuresearch Trials Of Dallas
state: Texas
city: Houston
country: United States
facility: Claghorn-Lesem Research Clinic
state: Texas
city: Houston
country: United States
facility: Medlabs Research Of Houston, Inc.
state: Texas
city: Houston
country: United States
facility: Red Oak Psychiatry Associates, Pa
state: Texas
city: Midlothian
country: United States
facility: Dominion Clinical Research
state: Virginia
city: Middleton
country: United States
facility: Dean Foundation For Health Research & Education
state: Wisconsin
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
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.