Experimental Medication For the Treatment of Generalized Anxiety Disorder
- Conditions
- Anxiety Disorder
- Registration Number
- NCT00097708
- Lead Sponsor
- Jazz Pharmaceuticals
- Brief Summary
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
- Detailed Description
Protocol 04-001-01
The primary objective of the study is to assess, under controlled conditions, the safety and efficacy of an experimental anti-anxiety medication relative to placebo in subjects with generalized anxiety disorder (GAD).
The secondary objective of the study is to study algorithms for discontinuation of an experimental anti-anxiety medication.
Recruiting: Participants are currently being recruited and enrolled.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 511
- Subjects 18 to 65 years of age will be eligible to participate if they satisfy the DSM-IV-TR criteria for the diagnosis of GAD.
- No other primary psychiatric diagnosis besides GAD.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in HAM-A Total Score Baseline to week 8 Hamilton Anxiety Rating Scale (HAM-A). Each of 14 symptoms categories is rated from 0=not present to 4=very severe. Numbers for all categories are summed to produce the total score. Total score ranges from 0=anxiety symptoms not present to 56=very severe anxiety symptoms across all 14 categories.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (49)
Princeton Medical Institute
🇺🇸Princeton, New Jersey, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Southwestern Research Institute
🇺🇸Burbank, California, United States
Southwesten Research, Inc.
🇺🇸Beverly Hills, California, United States
Crest Clinical Trials, Inc.
🇺🇸Anaheim, California, United States
Clinical Innovations
🇺🇸Santa Ana, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Florida Clinical Research Center
🇺🇸Bradenton, Florida, United States
Diablo Clinical Research, Inc.
🇺🇸Walnut Creek, California, United States
Sarkis Clinical Trials
🇺🇸Gainsville, Florida, United States
University Clinical Research DeLand, Inc.
🇺🇸DeLand, Florida, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
ACT Clinical Research
🇺🇸DeLand, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Orlando, Florida, United States
Institute of Research in Psychiatry
🇺🇸Tampa, Florida, United States
Meridien Research
🇺🇸St. Petersburg, Florida, United States
Janus Center for Psychiatric Research
🇺🇸West Palm Beach, Florida, United States
Atlanta Institute of Medicine and Research
🇺🇸Marietta, Georgia, United States
American Medical Research, Inc.
🇺🇸Oak Brook, Illinois, United States
Peak Medical Research, LLC
🇺🇸Owensboro, Kentucky, United States
New Orlean Medical Institute
🇺🇸Metairie, Louisiana, United States
Brentwood Research Institute
🇺🇸Shreveport, Louisiana, United States
Pivotal Research Centers - Detroit
🇺🇸Royal Oak, Michigan, United States
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
CNS Research Institute (CRI)
🇺🇸Clementon, New Jersey, United States
MedClin Research
🇺🇸St. Louis, Missouri, United States
ClinSearch, Inc.
🇺🇸Kenilworth, New Jersey, United States
Social Psychiatry Research Institute
🇺🇸Brooklyn, New York, United States
Midwest Clinical Research Center
🇺🇸Dayton, Ohio, United States
Neurology and Neuroscience Center of Ohio
🇺🇸Toledo, Ohio, United States
Oregon Center for Clinical Investigations, Inc.
🇺🇸Eugene, Oregon, United States
Laureate Psychiatric Clinic and Hospital
🇺🇸Tulsa, Oklahoma, United States
Southeast Health Consultants, LLC
🇺🇸Charleston, South Carolina, United States
CNS Research Institute
🇺🇸Philadelphia, Pennsylvania, United States
Suburban Research Associates
🇺🇸Media, Pennsylvania, United States
CNS, Inc.
🇺🇸Memphis, Tennessee, United States
FutureSearch Trials
🇺🇸Austin, Texas, United States
R/D Clinical Research, Inc.
🇺🇸Lake Jackson, Texas, United States
Research Across America
🇺🇸Dallas, Texas, United States
Comprehensive Neuroscience of Northern Virginia
🇺🇸Falls Church, Virginia, United States
Dominion Clinical Research, Inc.
🇺🇸Midlothian,, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
University of California - San Diego - Dept of Psychiatry
🇺🇸San Diego, California, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Clinical Research Associates, Inc.
🇺🇸Nashville, Tennessee, United States
Lifetree Clinical Research
🇺🇸Salt Lake City, Utah, United States
Birmingham Research Group, Inc.
🇺🇸Birmingham, Alabama, United States
Radiant Research
🇺🇸Boise, Idaho, United States