A 10-Week Efficacy and Safety Study of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
- Conditions
- Anxiety Disorder
- Registration Number
- NCT00236015
- Lead Sponsor
- Cephalon
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 880
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (51)
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Medark Clinical Trials and Research
🇺🇸Morganton, North Carolina, United States
Richard Weisler, MD and Associates
🇺🇸Raleigh, North Carolina, United States
Claghorn-Lesem Research Clinic, Inc.
🇺🇸Bellaire, Texas, United States
Center for Emotional Fitness
🇺🇸Moorestown, New Jersey, United States
Midwest Center for Neurobehavioral Medicine
🇺🇸Oakbrook Terrace, Illinois, United States
Fieve Clinical Services, Inc.
🇺🇸New York, New York, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Behavioral Medical Research of Staten Island
🇺🇸Staten Island, New York, United States
CNS Research Institute
🇺🇸Philadelphia, Pennsylvania, United States
Center for Addiction and Mental Health, Mood and Anxiety Program
🇨🇦Toronto, Ontario, Canada
Clinique Marie-Fitzbach,
🇨🇦Quebec, Canada
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Eugene, Oregon, United States
Mood Disorders Research Clinic; UT Southwestern Medical Center at Dallas
🇺🇸Dallas, Texas, United States
Keystone Clinical Studies, LLC
🇺🇸Norristown, Pennsylvania, United States
Pahl Pharmaceutical Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
University of Utah Mood Disorders Clinic
🇺🇸Salt Lake City, Utah, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Pivotol Research Centers
🇺🇸Mesa, Arizona, United States
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Clinical Innovations, Inc.
🇺🇸Santa Ana, California, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
Roskamp Institute, Clinical Trials Division
🇺🇸Sarasota, Florida, United States
Emory University
🇺🇸Atlanta, Georgia, United States
American Medical Research
🇺🇸Aurora, Illinois, United States
Indiana University Hospital AOC
🇺🇸Indianapolis, Indiana, United States
Henry Lahmeyer MD & Associates
🇺🇸Northfield, Illinois, United States
Pedia Research, LLC
🇺🇸Owensboro, Kentucky, United States
Vince & Associates Clinical Research
🇺🇸Overland Park, Kansas, United States
Four Rivers Clinical Research
🇺🇸Paducah, Kentucky, United States
LSU Health Science Center
🇺🇸Shreveport, Louisiana, United States
Dupont Clinical Research
🇺🇸Rockville, Maryland, United States
Regions Hospital - Department of Behavioral Health
🇺🇸St. Paul, Minnesota, United States
Center for Psychopharmacologic Research and Treatment
🇺🇸Worcester, Massachusetts, United States
Capital Clinical Research Associates
🇺🇸Rockville, Maryland, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Radiant Research Irvine
🇺🇸Irvine, California, United States
Croft Group Research Center
🇺🇸San Antonio, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Mood Disorders Clinic
🇨🇦Hamilton, Ontario, Canada
Dean Foundation
🇺🇸Middleton, Wisconsin, United States
St. Boniface General Hospital
🇨🇦Winnipeg, Manitoba, Canada
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Future Search Trials
🇺🇸Austin, Texas, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
University of British Columbia, Vancouver
🇨🇦Vancouver, British Columbia, Canada
Radiant Research
🇺🇸Las Vegas, Nevada, United States