A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
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.
1 other identifier
interventional
880
2 countries
54
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2004
Shorter than P25 for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
October 7, 2005
CompletedFirst Posted
Study publicly available on registry
October 12, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2006
CompletedMay 9, 2014
May 1, 2014
October 7, 2005
May 8, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cephalonlead
Study Sites (54)
Pivotol Research Centers
Mesa, Arizona, 85210, United States
Pivotal Research Center
Peoria, Arizona, 85381, United States
Valley Clinical Research
El Centro, California, 92243, United States
Radiant Research Irvine
Irvine, California, 92618, United States
Pharmacology Research Institute
Los Alamitos, California, 90720, United States
Pharmacology Research Institute
Riverside, California, 92506, United States
Clinical Innovations, Inc.
Santa Ana, California, 92705, United States
Radiant Research
Denver, Colorado, 80212, United States
University of Connecticut Health Center
Farmington, Connecticut, 06030-6415, United States
Miami Research Associates
Miami, Florida, 33173, United States
Medical Research Group of Central Florida
Orange City, Florida, 32763, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Roskamp Institute, Clinical Trials Division
Sarasota, Florida, 34243, United States
Stedman Clinical Trials
Tampa, Florida, 33613, United States
Emory University
Atlanta, Georgia, 30329, United States
American Medical Research
Aurora, Illinois, 60506, United States
Henry Lahmeyer MD & Associates
Northfield, Illinois, 60093, United States
Midwest Center for Neurobehavioral Medicine
Oakbrook Terrace, Illinois, 60181, United States
Indiana University Hospital AOC
Indianapolis, Indiana, 46202, United States
Vince & Associates Clinical Research
Overland Park, Kansas, 66211, United States
Pedia Research, LLC
Owensboro, Kentucky, 42301, United States
Four Rivers Clinical Research
Paducah, Kentucky, 42003, United States
LSU Health Science Center
Shreveport, Louisiana, 71103, United States
Capital Clinical Research Associates
Rockville, Maryland, 20852, United States
Dupont Clinical Research
Rockville, Maryland, 20852, United States
Center for Psychopharmacologic Research and Treatment
Worcester, Massachusetts, 01605, United States
Wayne State University
Detroit, Michigan, 48207, United States
Regions Hospital - Department of Behavioral Health
Saint Paul, Minnesota, 55101, United States
Radiant Research
Las Vegas, Nevada, 89146, United States
Center for Emotional Fitness
Moorestown, New Jersey, 08057, United States
Fieve Clinical Services, Inc.
New York, New York, 10021, United States
Behavioral Medical Research of Staten Island
Staten Island, New York, 10305, United States
Medark Clinical Trials and Research
Morganton, North Carolina, 28655, United States
Richard Weisler, MD and Associates
Raleigh, North Carolina, 27609, United States
Wake Research Associates, LLC
Raleigh, North Carolina, 27612, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Pahl Pharmaceutical Research, LLC
Oklahoma City, Oklahoma, 73118, United States
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, 19401, United States
CNS Research Institute
Philadelphia, Pennsylvania, 19149, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119, United States
Future Search Trials
Austin, Texas, 78756, United States
Claghorn-Lesem Research Clinic, Inc.
Bellaire, Texas, 77401, United States
Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas
Dallas, Texas, 75235, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Croft Group Research Center
San Antonio, Texas, 78229, United States
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, 84132, United States
Dean Foundation
Middleton, Wisconsin, 53562, United States
University of Alberta
Edmonton, Alberta, T6G 2C8, Canada
University of British Columbia, Vancouver
Vancouver, British Columbia, V6T 2A1, Canada
St. Boniface General Hospital
Winnipeg, Manitoba, R2H 2A6, Canada
Mood Disorders Clinic
Hamilton, Ontario, L8N 3Z5, Canada
Center for Addiction and Mental Health, Mood and Anxiety Program
Toronto, Ontario, M5T 1R8, Canada
Clinique Marie-Fitzbach,
Québec, Quebec, GIR 2W8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
October 7, 2005
First Posted
October 12, 2005
Study Start
November 1, 2004
Study Completion
March 1, 2006
Last Updated
May 9, 2014
Record last verified: 2014-05