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

May 8, 2014 updated by: Cephalon

A 10-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Gabitril at 4, 8, and 12 mg/Day in the Treatment of Adults With Generalized Anxiety Disorder.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

880

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Quebec, Canada, GIR 2W8
        • Clinique Marie-Fitzbach,
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2C8
        • University of Alberta
    • British Columbia
      • Vancouver, British Columbia, Canada, V6T 2A1
        • University of British Columbia, Vancouver
    • Manitoba
      • Winnipeg, Manitoba, Canada, R2H 2A6
        • St. Boniface General Hospital
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Mood Disorders Clinic
      • Toronto, Ontario, Canada, M5t 1R8
        • Center for Addiction and Mental Health, Mood and Anxiety Program
  • United States
    • Arizona
      • Mesa, Arizona, United States, 85210
        • Pivotol Research Centers
      • Peoria, Arizona, United States, 85381
        • Pivotal Research Center
    • California
      • El Centro, California, United States, 92243
        • Valley Clinical Research
      • Irvine, California, United States, 92618
        • Radiant Research Irvine
      • Los Alamitos, California, United States, 90720
        • Pharmacology Research Institute
      • Riverside, California, United States, 92506
        • Pharmacology Research Institute
      • Santa Ana, California, United States, 92705
        • Clinical Innovations, Inc.
    • Colorado
      • Denver, Colorado, United States, 80212
        • Radiant Research
    • Connecticut
      • Farmington, Connecticut, United States, 06030-6415
        • University of Connecticut Health Center
    • Florida
      • Miami, Florida, United States, 33173
        • Miami Research Associates
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32806
        • Clinical Neuroscience Solutions, INC.
      • Sarasota, Florida, United States, 34243
        • Roskamp Institute, Clinical Trials Division
      • Tampa, Florida, United States, 33613
        • Stedman Clinical Trials
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Emory University
    • Illinois
      • Aurora, Illinois, United States, 60506
        • American Medical Research
      • Northfield, Illinois, United States, 60093
        • Henry Lahmeyer MD & Associates
      • Oakbrook Terrace, Illinois, United States, 60181
        • Midwest Center for Neurobehavioral Medicine
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Hospital AOC
    • Kansas
      • Overland Park, Kansas, United States, 66211
        • Vince & Associates Clinical Research
    • Kentucky
      • Owensboro, Kentucky, United States, 42301
        • Pedia Research, LLC
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Science Center
    • Maryland
      • Rockville, Maryland, United States, 20852
        • Capital Clinical Research Associates
      • Rockville, Maryland, United States, 20852
        • Dupont Clinical Research
    • Massachusetts
      • Worcester, Massachusetts, United States, 01605
        • Center for Psychopharmacologic Research and Treatment
    • Michigan
      • Detroit, Michigan, United States, 48207
        • Wayne State University
    • Minnesota
      • St. Paul, Minnesota, United States, 55101
        • Regions Hospital - Department of Behavioral Health
    • Nevada
      • Las Vegas, Nevada, United States, 89146
        • Radiant Research
    • New Jersey
      • Moorestown, New Jersey, United States, 08057
        • Center for Emotional Fitness
    • New York
      • New York, New York, United States, 10021
        • Fieve Clinical Services, Inc.
      • Staten Island, New York, United States, 10305
        • Behavioral Medical Research Of Staten Island
    • North Carolina
      • Morganton, North Carolina, United States, 28655
        • Medark Clinical Trials and Research
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Raleigh, North Carolina, United States, 27609
        • Richard Weisler, MD and Associates
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Midwest Clinical Research Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73118
        • Pahl Pharmaceutical Research, LLC
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Center for Clinical Investigations, Inc.
    • Pennsylvania
      • Norristown, Pennsylvania, United States, 19401
        • Keystone Clinical Studies, LLC
      • Philadelphia, Pennsylvania, United States, 19149
        • CNS Research Institute
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, INC.
    • Texas
      • Austin, Texas, United States, 78756
        • Future Search Trials
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic, Inc.
      • Dallas, Texas, United States, 75235
        • Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas
      • Lake Jackson, Texas, United States, 77566
        • R/D Clinical Research, Inc.
      • San Antonio, Texas, United States, 78229
        • Croft Group Research Center
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Mood Disorders Clinic
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
        • Dean Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Reduction of symptomatology associated with Generalized Anxiety Disorder as assessed by the change from baseline to end point in the total score of the HAM-A scale.

Secondary Outcome Measures

Outcome Measure
Assessment of proportion of responders and patients in remission according to HAM-A scores and CGI ratings by visit, assessment of the safety and tolerability in patients with GAD

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cephalon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Study Completion

March 1, 2006

Study Registration Dates

First Submitted

October 7, 2005

First Submitted That Met QC Criteria

October 7, 2005

First Posted (ESTIMATE)

October 12, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 8, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C6671/3030/AX/US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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