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

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

Resource links provided by NLM:

MedlinePlus related topics: Anxiety

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

U.S. FDA Resources

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

Additional 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

No publications provided

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 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Neurotransmitter Agents
Cholinergic Antagonists
Psychotropic Drugs
Cholinergic Agents
Serotonin Uptake Inhibitors
Citalopram
Serotonin

Muscarinic Antagonists
Anxiety Disorders
Mental Disorders
Peripheral Nervous System Agents
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:

Parasympatholytics
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Cholinergic Agents
Pathologic Processes
Mental Disorders
Therapeutic Uses

Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Citalopram
Serotonin Uptake Inhibitors
Pharmacologic Actions
Muscarinic Antagonists
Serotonin Agents
Anxiety Disorders
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 11, 2009