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

This study has been completed.
Sponsor:
Information provided by:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00481325
First received: May 31, 2007
Last updated: September 10, 2010
Last verified: October 2008
  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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


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
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

  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
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, see Learn About Clinical Studies.

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 Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00481325     History of Changes
Other Study ID Numbers: CN148-015
Study First Received: May 31, 2007
Last Updated: September 10, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Dexetimide
Citalopram
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Serotonin Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on October 01, 2014