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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00481325
Recruitment Status : Completed
First Posted : June 1, 2007
Last Update Posted : October 12, 2015
Sponsor:
Information provided by:
Bristol-Myers Squibb

Tracking Information
First Submitted Date  ICMJE May 31, 2007
First Posted Date  ICMJE June 1, 2007
Last Update Posted Date October 12, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 31, 2007)
Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) [ Time Frame: Week 8 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2007)
  • Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Week 8 ]
  • Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score [ Time Frame: Week 8 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Pexacerfont (BMS-562086) in the Treatment of Outpatients With Generalized Anxiety Disorder
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Generalized Anxiety Disorder
Intervention  ICMJE
  • Drug: pexacerfont
    Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
    Other Name: (BMS-562086)
  • Drug: escitalopram
    Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
  • Drug: placebo
    Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks
Study Arms  ICMJE
  • Experimental: A1
    Intervention: Drug: pexacerfont
  • Active Comparator: A2
    Intervention: Drug: escitalopram
  • Placebo Comparator: A3
    Intervention: Drug: placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 14, 2008)
260
Original Estimated Enrollment  ICMJE
 (submitted: May 31, 2007)
257
Actual Study Completion Date  ICMJE March 2008
Actual Primary Completion Date March 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00481325
Other Study ID Numbers  ICMJE CN148-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Study Director, Bristol-Myers Squibb
Study Sponsor  ICMJE Bristol-Myers Squibb
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
PRS Account Bristol-Myers Squibb
Verification Date September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP