A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder

NCT ID: NCT00236015

Last Updated: 2014-05-09

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

PHASE3

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2006-03-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of an investigational anti-anxiety medication relative to placebo in patients with generalized anxiety disorder (GAD).

Detailed Description

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Conditions

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Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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Gabitril

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects 18 to 64 years of age (inclusive) will be eligible to participate if they satisfy the DSM-IV-TR criteria for GAD, as well as meeting the required screening and baseline visit scores for a series of psychiatric evaluations (i.e., HAM-A, HADS, MADRS and CGI-S).

Exclusion Criteria

* Have been previously unresponsive to two or more adequate courses of pharmacological treatment for GAD
* Have been diagnosed with any other psychiatric Axis I disorder (except GAD) as a principal diagnosis within the past six months
* Have been diagnosed with any eating disorder within the past six months
* Have any history of OCD, psychotic disorder, bipolar disorder or antisocial personality disorder
* Have any history of alcohol or substance abuse within 3 months of screening
* Have any history of seizures, including febrile seizures
* Have any history of head trauma associated with loss of consciousness within the past 15 years
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cephalon

INDUSTRY

Sponsor Role lead

Locations

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Pivotol Research Centers

Mesa, Arizona, United States

Site Status

Pivotal Research Center

Peoria, Arizona, United States

Site Status

Valley Clinical Research

El Centro, California, United States

Site Status

Radiant Research Irvine

Irvine, California, United States

Site Status

Pharmacology Research Institute

Los Alamitos, California, United States

Site Status

Pharmacology Research Institute

Riverside, California, United States

Site Status

Clinical Innovations, Inc.

Santa Ana, California, United States

Site Status

Radiant Research

Denver, Colorado, United States

Site Status

University of Connecticut Health Center

Farmington, Connecticut, United States

Site Status

Miami Research Associates

Miami, Florida, United States

Site Status

Medical Research Group of Central Florida

Orange City, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

Roskamp Institute, Clinical Trials Division

Sarasota, Florida, United States

Site Status

Stedman Clinical Trials

Tampa, Florida, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

American Medical Research

Aurora, Illinois, United States

Site Status

Henry Lahmeyer MD & Associates

Northfield, Illinois, United States

Site Status

Midwest Center for Neurobehavioral Medicine

Oakbrook Terrace, Illinois, United States

Site Status

Indiana University Hospital AOC

Indianapolis, Indiana, United States

Site Status

Vince & Associates Clinical Research

Overland Park, Kansas, United States

Site Status

Pedia Research, LLC

Owensboro, Kentucky, United States

Site Status

Four Rivers Clinical Research

Paducah, Kentucky, United States

Site Status

LSU Health Science Center

Shreveport, Louisiana, United States

Site Status

Capital Clinical Research Associates

Rockville, Maryland, United States

Site Status

Dupont Clinical Research

Rockville, Maryland, United States

Site Status

Center for Psychopharmacologic Research and Treatment

Worcester, Massachusetts, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Regions Hospital - Department of Behavioral Health

Saint Paul, Minnesota, United States

Site Status

Radiant Research

Las Vegas, Nevada, United States

Site Status

Center for Emotional Fitness

Moorestown, New Jersey, United States

Site Status

Fieve Clinical Services, Inc.

New York, New York, United States

Site Status

Behavioral Medical Research of Staten Island

Staten Island, New York, United States

Site Status

Medark Clinical Trials and Research

Morganton, North Carolina, United States

Site Status

Richard Weisler, MD and Associates

Raleigh, North Carolina, United States

Site Status

Wake Research Associates, LLC

Raleigh, North Carolina, United States

Site Status

Midwest Clinical Research Center

Dayton, Ohio, United States

Site Status

Pahl Pharmaceutical Research, LLC

Oklahoma City, Oklahoma, United States

Site Status

Oregon Center for Clinical Investigations, Inc.

Eugene, Oregon, United States

Site Status

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, United States

Site Status

CNS Research Institute

Philadelphia, Pennsylvania, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

Future Search Trials

Austin, Texas, United States

Site Status

Claghorn-Lesem Research Clinic, Inc.

Bellaire, Texas, United States

Site Status

Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

R/D Clinical Research, Inc.

Lake Jackson, Texas, United States

Site Status

Croft Group Research Center

San Antonio, Texas, United States

Site Status

University of Utah Mood Disorders Clinic

Salt Lake City, Utah, United States

Site Status

Dean Foundation

Middleton, Wisconsin, United States

Site Status

University of Alberta

Edmonton, Alberta, Canada

Site Status

University of British Columbia, Vancouver

Vancouver, British Columbia, Canada

Site Status

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Site Status

Mood Disorders Clinic

Hamilton, Ontario, Canada

Site Status

Center for Addiction and Mental Health, Mood and Anxiety Program

Toronto, Ontario, Canada

Site Status

Clinique Marie-Fitzbach,

Québec, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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C6671/3030/AX/US

Identifier Type: -

Identifier Source: org_study_id

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