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Completed

NCT Number: NCT00481325

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

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

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Pivotal Research Centers, Mesa, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pexacerfont

Drug

Tablets & Capsules, Oral, 300mg loading dose then 100 mg, once daily, 1 week loading dose then 8 weeks

Other names: (BMS-562086)

Escitalopram

Drug

Tablets & Capsules, Oral, 10-20mg, once daily, 1 week loading dose then 8 weeks

Placebo

Drug

Tablets & Capsules, Oral, 0 mg, once daily, 1 week loading dose then 8 weeks

Primary outcomes

  1. Mean change from baseline to Week 8 on the Site-Rated Hamilton Anxiety Rating Scale (total score)

    Time frame: Week 8

Secondary outcomes

  1. Mean change from baseline to Week 8 on the Sheehan Disability Scale (SDS) Total Score

    Time frame: Week 8

  2. Mean change from baseline to Week 8 on the Gastrointestinal Symptom Index Total Score

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study 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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jun 1, 2007
Registry last updated
Oct 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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