A 10-Week Efficacy and Safety Study for of Gabitril in the Treatment of Adults With Generalized Anxiety Disorder
- Conditions
- Generalized Anxiety Disorder
- Registration Number
- NCT00236054
- 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
- 440
- 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 the past 3 months
- 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 endpoint 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 (19)
Cunningham Clinical Research, LLC
🇺🇸Edwardsville, Illinois, United States
Health Quest Clinical Trials
🇺🇸San Diego, California, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Hartford Research Group Ltd.
🇺🇸Cincinnati, Ohio, United States
Pacific Institute for Medical Research, Inc.
🇺🇸Los Angeles, California, United States
Pharmacology Research Institute
🇺🇸Newport Beach, California, United States
Affiliated Research Institute
🇺🇸San Diego, California, United States
Pacific Clinical Research Medical Group
🇺🇸Upland, California, United States
UF Behavioral Health Clinic
🇺🇸Jacksonville, Florida, United States
Atlanta Institute of Medicine & Research - Atlanta Clinic
🇺🇸Atlanta, Georgia, United States
LSUHSC Anxiety and Mood Disorders Clinic
🇺🇸New Orleans, Louisiana, United States
Summit Research Network
🇺🇸Farmington Hills, Michigan, United States
Social Psychiatry Research Inst.
🇺🇸Brooklyn, New York, United States
Eastside Comprehensive Medical Center
🇺🇸New York, New York, United States
Medical and Behavioral Health Research, PC
🇺🇸New York, New York, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Salem, Oregon, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
South East Health Consultants, LLC
🇺🇸Charleston, South Carolina, United States
Northbrooke Research
🇺🇸Brown Deer, Wisconsin, United States