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

Phase 2

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Drug: pexacerfont; Drug: placebo; Drug: escitalopram

• 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

Study Timeline

• Study First Submitted: 2007-05-31
• Study First Submitted QC: 2007-05-31
• Study First Posted: 2007-06-01
• Study Start: 2007-07
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Disposition First Submitted: 2010-09-10
• Disposition First Submitted QC: 2010-09-10
• Disposition First Posted: 2010-09-14
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-23
• Last Update Posted: 2015-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 260

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

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)

Pivotal Research Centers; 🇺🇸 Mesa, Arizona, United States

Pacific Clinical Research Medical Group; 🇺🇸 Upland, 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

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

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