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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

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

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Drug: pexacerfont Drug: escitalopram Drug: placebo Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 260 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : July 2007
Actual Primary Completion Date : March 2008
Actual Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: A1 Drug: pexacerfont
Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
Other Name: (BMS-562086)
Active Comparator: A2 Drug: escitalopram
Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
Placebo Comparator: A3 Drug: placebo
Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) [ Time Frame: Week 8 ]

Secondary Outcome Measures :
  1. Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Week 8 ]
  2. Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score [ Time Frame: Week 8 ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00481325


Locations
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Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00481325    
Other Study ID Numbers: CN148-015
First Posted: June 1, 2007    Key Record Dates
Last Update Posted: October 12, 2015
Last Verified: September 2015
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders
Escitalopram
Selective Serotonin Reuptake Inhibitors
Neurotransmitter Uptake Inhibitors
 Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs