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

NCT ID: NCT00236054

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

440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2005-12-31

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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Generalized Anxiety Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

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 the past 3 months
* 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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Pacific Institute for Medical Research, Inc.

Los Angeles, California, United States

Site Status

Pharmacology Research Institute

Newport Beach, California, United States

Site Status

Affiliated Research Institute

San Diego, California, United States

Site Status

Health Quest Clinical Trials

San Diego, California, United States

Site Status

Pacific Clinical Research Medical Group

Upland, California, United States

Site Status

UF Behavioral Health Clinic

Jacksonville, Florida, United States

Site Status

Janus Center for Psychiatric Research

West Palm Beach, Florida, United States

Site Status

Atlanta Institute of Medicine & Research - Atlanta Clinic

Atlanta, Georgia, United States

Site Status

Cunningham Clinical Research, LLC

Edwardsville, Illinois, United States

Site Status

LSUHSC Anxiety and Mood Disorders Clinic

New Orleans, Louisiana, United States

Site Status

Summit Research Network

Farmington Hills, Michigan, United States

Site Status

Social Psychiatry Research Inst.

Brooklyn, New York, United States

Site Status

Eastside Comprehensive Medical Center

New York, New York, United States

Site Status

Medical and Behavioral Health Research, PC

New York, New York, United States

Site Status

Hartford Research Group Ltd.

Cincinnati, Ohio, United States

Site Status

Oregon Center for Clinical Investigations, Inc.

Salem, Oregon, United States

Site Status

South East Health Consultants, LLC

Charleston, South Carolina, United States

Site Status

Northwest Clinical Research Center

Bellevue, Washington, United States

Site Status

Northbrooke Research

Brown Deer, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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C6671/3032/AX/US

Identifier Type: -

Identifier Source: org_study_id

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