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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Generalized Anxiety Disorder

Treatments: Drug: placebo; Drug: escitalopram; Drug: pexacerfont

Study type: Interventional

Funder types: Industry

Identifiers

NCT00481325

CN148-015

Details and patient eligibility

About

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

Enrollment: 260 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 3 patient groups, including a placebo group

A1

Experimental group

Treatment:

Drug: pexacerfont

A2

Active Comparator group

Treatment:

Drug: escitalopram

A3

Placebo Comparator group

Treatment:

Drug: placebo