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

This study has been completed.
Sponsor:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00236015
First received: October 7, 2005
Last updated: May 8, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Anxiety Disorder
Drug: Gabitril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 880
Study Start Date: November 2004
Estimated Study Completion Date: March 2006
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00236015

  Hide Study Locations
Locations
United States, Arizona
Pivotol Research Centers
Mesa, Arizona, United States, 85210
Pivotal Research Center
Peoria, Arizona, United States, 85381
United States, California
Valley Clinical Research
El Centro, California, United States, 92243
Radiant Research Irvine
Irvine, California, United States, 92618
Pharmacology Research Institute
Los Alamitos, California, United States, 90720
Pharmacology Research Institute
Riverside, California, United States, 92506
Clinical Innovations, Inc.
Santa Ana, California, United States, 92705
United States, Colorado
Radiant Research
Denver, Colorado, United States, 80212
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-6415
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33173
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32806
Roskamp Institute, Clinical Trials Division
Sarasota, Florida, United States, 34243
Stedman Clinical Trials
Tampa, Florida, United States, 33613
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
United States, Illinois
American Medical Research
Aurora, Illinois, United States, 60506
Henry Lahmeyer MD & Associates
Northfield, Illinois, United States, 60093
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, United States, 60181
United States, Indiana
Indiana University Hospital AOC
Indianapolis, Indiana, United States, 46202
United States, Kansas
Vince & Associates Clinical Research
Overland Park, Kansas, United States, 66211
United States, Kentucky
Pedia Research, LLC
Owensboro, Kentucky, United States, 42301
Four Rivers Clinical Research
Paducah, Kentucky, United States, 42003
United States, Louisiana
LSU Health Science Center
Shreveport, Louisiana, United States, 71103
United States, Maryland
Capital Clinical Research Associates
Rockville, Maryland, United States, 20852
Dupont Clinical Research
Rockville, Maryland, United States, 20852
United States, Massachusetts
Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts, United States, 01605
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48207
United States, Minnesota
Regions Hospital - Department of Behavioral Health
St. Paul, Minnesota, United States, 55101
United States, Nevada
Radiant Research
Las Vegas, Nevada, United States, 89146
United States, New Jersey
Center for Emotional Fitness
Moorestown, New Jersey, United States, 08057
United States, New York
Fieve Clinical Services, Inc.
New York, New York, United States, 10021
Behavioral Medical Research of Staten Island
Staten Island, New York, United States, 10305
United States, North Carolina
Medark Clinical Trials and Research
Morganton, North Carolina, United States, 28655
Richard Weisler, MD and Associates
Raleigh, North Carolina, United States, 27609
Wake Research Associates, LLC
Raleigh, North Carolina, United States, 27612
United States, Ohio
Midwest Clinical Research Center
Dayton, Ohio, United States, 45408
United States, Oklahoma
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, United States, 73118
United States, Oregon
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, United States, 97401
United States, Pennsylvania
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States, 19401
CNS Research Institute
Philadelphia, Pennsylvania, United States, 19149
United States, Tennessee
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
United States, Texas
Future Search Trials
Austin, Texas, United States, 78756
Claghorn-Lesem Research Clinic, Inc.
Bellaire, Texas, United States, 77401
Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
R/D Clinical Research, Inc.
Lake Jackson, Texas, United States, 77566
Croft Group Research Center
San Antonio, Texas, United States, 78229
United States, Utah
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, United States, 84132
United States, Wisconsin
Dean Foundation
Middleton, Wisconsin, United States, 53562
Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2C8
Canada, British Columbia
University of British Columbia, Vancouver
Vancouver, British Columbia, Canada, V6T 2A1
Canada, Manitoba
St. Boniface General Hospital
Winnipeg, Manitoba, Canada, R2H 2A6
Canada, Ontario
Mood Disorders Clinic
Hamilton, Ontario, Canada, L8N 3Z5
Center for Addiction and Mental Health, Mood and Anxiety Program
Toronto, Ontario, Canada, M5T 1R8
Canada
Clinique Marie-Fitzbach,
Quebec, Canada, GIR 2W8
Sponsors and Collaborators
Cephalon
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00236015     History of Changes
Other Study ID Numbers: C6671/3030/AX/US
Study First Received: October 7, 2005
Last Updated: May 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes
Tiagabine
Anticonvulsants
Central Nervous System Agents
GABA Agents
GABA Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014