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

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00481325

Purpose

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

Condition	Intervention	Phase
Generalized Anxiety Disorder	Drug: pexacerfont Drug: escitalopram Drug: placebo	Phase II Phase III

MedlinePlus related topics: Anxiety

Drug Information available for: Escitalopram Benzetimide Citalopram Citalopram hydrobromide Dexetimide Escitalopram oxalate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score) [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Enrollment:	260
Study Start Date:	July 2007
Study Completion Date:	March 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A1: Experimental	Drug: pexacerfont Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks
A2: Active Comparator	Drug: escitalopram Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks
A3: Placebo Comparator	Drug: placebo Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders 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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00481325

Show 51 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	CN148-015
Study First Received:	May 31, 2007
Last Updated:	October 14, 2008
ClinicalTrials.gov Identifier:	NCT00481325
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Anxiety Disorders
Mental Disorders
Dexetimide
Citalopram
Serotonin

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents

Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 13, 2009