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

NCT ID: NCT00236067

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

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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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 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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Birmingham Research Group

Birmingham, Alabama, United States

Site Status

Southwestern Research Institute

Beverly Hills, California, United States

Site Status

Pharmacology Research Institute

Northridge, California, United States

Site Status

Pacific Clinical Research

Orange, California, United States

Site Status

Carman Research

Smyrna, Georgia, United States

Site Status

Hawaii Clinical Research Center

Honolulu, Hawaii, United States

Site Status

Hartford Research Group

Florence, Kentucky, United States

Site Status

Summit Research Network

Okemos, Michigan, United States

Site Status

CNS Research Institute

Clementon, New Jersey, United States

Site Status

Social Psychiatry Research Inst.

Brooklyn, New York, United States

Site Status

Neurobehavioral Research, Inc.

Lawrence, New York, United States

Site Status

Social Psychiatry Research Inst.

New York, New York, United States

Site Status

The Medical Research Network

New York, New York, United States

Site Status

Northcoast Clinical Trials

Beachwood, Ohio, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Summit Research Network

Portland, Oregon, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Carolina Clinical Research Services

Columbia, South Carolina, United States

Site Status

Radiant Research, Salt Lake City

Salt Lake City, Utah, United States

Site Status

Comprehensive Neuroscience of Northern Virginia

Arlington, Virginia, United States

Site Status

Summit Research Network

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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C6671/3031/AX/US

Identifier Type: -

Identifier Source: org_study_id

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