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

NCT ID: NCT00481325

Last Updated: 2015-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2008-03-31

Brief Summary

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

Detailed Description

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Conditions

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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A1

Group Type EXPERIMENTAL

pexacerfont

Intervention Type DRUG

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

A2

Group Type ACTIVE_COMPARATOR

escitalopram

Intervention Type DRUG

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

A3

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

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

Interventions

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pexacerfont

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

Intervention Type DRUG

escitalopram

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

Intervention Type DRUG

placebo

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

Intervention Type DRUG

Other Intervention Names

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(BMS-562086)

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Pivotal Research Centers

Mesa, Arizona, United States

Site Status

Pacific Clinical Research Medical Group

Burbank, California, United States

Site Status

Us Clinical Research Centers, Llc

Costa Mesa, California, United States

Site Status

Pacific Institute For Medical Research, Inc.

Los Angeles, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

Site Status

Radiant Research, Inc.

Denver, Colorado, United States

Site Status

University Of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Comprehensive Psychiatric Care, Pc

Norwich, Connecticut, United States

Site Status

Meridien Research

Brooksville, Florida, United States

Site Status

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

Site Status

Comprehensive Neuroscience, Inc.

St. Petersburg, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Janus Center For Psychiatric Research

West Palm Beach, Florida, United States

Site Status

Carman Research

Smyrna, Georgia, United States

Site Status

Indiana University School Of Medicine

Indianapolis, Indiana, United States

Site Status

Alpine Clinic

Lafayette, Indiana, United States

Site Status

Cientifica, Inc. At Prairie View Inc.

Newton, Kansas, United States

Site Status

Ctt, Inc.

Prairie Village, Kansas, United States

Site Status

J. Gary Booker, Md, Apmc

Shreveport, Louisiana, United States

Site Status

Pharmasite Research, Inc.

Baltimore, Maryland, United States

Site Status

Capital Clinical Research Associates

Rockville, Maryland, United States

Site Status

Boston Clinical Trials, Inc.

Boston, Massachusetts, United States

Site Status

Regions Hospital

Saint Paul, Minnesota, United States

Site Status

Neurobehavioral Research, Inc.

Cedarhurst, New York, United States

Site Status

Bioscience Research, Llc

New York, New York, United States

Site Status

Fieve Clinical Services, Inc.

New York, New York, United States

Site Status

Social Psychiatry Research Institute

New York, New York, United States

Site Status

Behavioral Medical Research Of Staten Island

Staten Island, New York, United States

Site Status

Richmond Behavioral Associates

Staten Island, New York, United States

Site Status

North Carolina Neuropsychiatry, Pa

Charlotte, North Carolina, United States

Site Status

Medark Clinical Research

Morganton, North Carolina, United States

Site Status

Psychiatry And Clinical Research

Raleigh, North Carolina, United States

Site Status

Community Research

Cincinnati, Ohio, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Ips Research Company

Oklahoma City, Oklahoma, United States

Site Status

University Of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Oregon Center For Clinical Investigations, Inc. (Occi, Inc)

Salem, Oregon, United States

Site Status

Lehigh Valley Hospital

Allentown, Pennsylvania, United States

Site Status

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Site Status

Medical University Of South Carolina

Charleston, South Carolina, United States

Site Status

Carolina Clinical Research Services, Llc

Columbia, South Carolina, United States

Site Status

Avera Research Institute

Sioux Falls, South Dakota, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Futuresearch Trials

Austin, Texas, United States

Site Status

Futuresearch Trials Of Dallas

Dallas, Texas, United States

Site Status

Claghorn-Lesem Research Clinic

Houston, Texas, United States

Site Status

Medlabs Research Of Houston, Inc.

Houston, Texas, United States

Site Status

Red Oak Psychiatry Associates, Pa

Houston, Texas, United States

Site Status

Dominion Clinical Research

Midlothian, Virginia, United States

Site Status

Dean Foundation For Health Research & Education

Middleton, Wisconsin, United States

Site Status

Countries

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United States

References

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Coric V, Feldman HH, Oren DA, Shekhar A, Pultz J, Dockens RC, Wu X, Gentile KA, Huang SP, Emison E, Delmonte T, D'Souza BB, Zimbroff DL, Grebb JA, Goddard AW, Stock EG. Multicenter, randomized, double-blind, active comparator and placebo-controlled trial of a corticotropin-releasing factor receptor-1 antagonist in generalized anxiety disorder. Depress Anxiety. 2010 May;27(5):417-25. doi: 10.1002/da.20695.

Reference Type DERIVED
PMID: 20455246 (View on PubMed)

Other Identifiers

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CN148-015

Identifier Type: -

Identifier Source: org_study_id

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