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)
Pivotol Research Centers
🇺🇸Mesa, Arizona, United States
Pivotal Research Center
🇺🇸Peoria, Arizona, United States
Valley Clinical Research
🇺🇸El Centro, California, United States
Radiant Research Irvine
🇺🇸Irvine, California, United States
Pharmacology Research Institute
🇺🇸Riverside, California, United States
Clinical Innovations, Inc.
🇺🇸Santa Ana, California, United States
Radiant Research
🇺🇸Las Vegas, Nevada, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Miami Research Associates
🇺🇸Miami, Florida, United States
Medical Research Group of Central Florida
🇺🇸Orange City, Florida, United States
Scroll for more (41 remaining)Pivotol Research Centers🇺🇸Mesa, Arizona, United States