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

Generalized Anxiety Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00481325
• Other study ID #: CN148-015
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: May 31, 2007
• Last updated: September 23, 2015
• Start date: July 2007
• Est. completion date: March 2008

Study information

• Verified date: September 2015
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 260
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	Lehigh Valley Hospital	Allentown	Pennsylvania
United States	Futuresearch Trials	Austin	Texas
United States	Pharmasite Research, Inc.	Baltimore	Maryland
United States	Boston Clinical Trials, Inc.	Boston	Massachusetts
United States	Meridien Research	Brooksville	Florida
United States	Pacific Clinical Research Medical Group	Burbank	California
United States	Neurobehavioral Research, Inc.	Cedarhurst	New York
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	North Carolina Neuropsychiatry, Pa	Charlotte	North Carolina
United States	Community Research	Cincinnati	Ohio
United States	Carolina Clinical Research Services, Llc	Columbia	South Carolina
United States	Us Clinical Research Centers, Llc	Costa Mesa	California
United States	Futuresearch Trials Of Dallas	Dallas	Texas
United States	Midwest Clinical Research Center	Dayton	Ohio
United States	Radiant Research, Inc.	Denver	Colorado
United States	Rhode Island Mood & Memory Research Institute	East Providence	Rhode Island
United States	University Of Connecticut Health Center	Farmington	Connecticut
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	Indiana University School Of Medicine	Indianapolis	Indiana
United States	Clinical Neuroscience Solutions	Jacksonville	Florida
United States	Alpine Clinic	Lafayette	Indiana
United States	Pacific Institute For Medical Research, Inc.	Los Angeles	California
United States	Clinical Neuroscience Solutions, Inc.	Memphis	Tennessee
United States	Pivotal Research Centers	Mesa	Arizona
United States	Dean Foundation For Health Research & Education	Middleton	Wisconsin
United States	Dominion Clinical Research	Midlothian	Virginia
United States	Medark Clinical Research	Morganton	North Carolina
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	Cientifica, Inc. At Prairie View Inc.	Newton	Kansas
United States	Comprehensive Psychiatric Care, Pc	Norwich	Connecticut
United States	Ips Research Company	Oklahoma City	Oklahoma
United States	University Of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	Ctt, Inc.	Prairie Village	Kansas
United States	Psychiatry And Clinical Research	Raleigh	North Carolina
United States	Capital Clinical Research Associates	Rockville	Maryland
United States	Oregon Center For Clinical Investigations, Inc. (Occi, Inc)	Salem	Oregon
United States	Affiliated Research Institute	San Diego	California
United States	J. Gary Booker, Md, Apmc	Shreveport	Louisiana
United States	Avera Research Institute	Sioux Falls	South Dakota
United States	Carman Research	Smyrna	Georgia
United States	Comprehensive Neuroscience, Inc.	St Petersburg	Florida
United States	Regions Hospital	St. Paul	Minnesota
United States	Behavioral Medical Research Of Staten Island	Staten Island	New York
United States	Richmond Behavioral Associates	Staten Island	New York
United States	Stedman Clinical Trials	Tampa	Florida
United States	Pacific Clinical Research Medical Group	Upland	California
United States	Janus Center For Psychiatric Research	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)		Week 8	No
Secondary	Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score		Week 8	No
Secondary	Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score		Week 8	No

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm