Experimental Medication For the Treatment of Generalized Anxiety Disorder
A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
1 other identifier
interventional
511
1 country
50
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Nov 2004
Shorter than P25 for phase_3
50 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
November 29, 2004
CompletedFirst Posted
Study publicly available on registry
November 30, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
October 3, 2014
CompletedOctober 3, 2014
October 1, 2014
November 29, 2004
September 14, 2011
October 1, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HAM-A Total Score
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.
Baseline to week 8
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- No other primary psychiatric diagnosis besides GAD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (50)
Birmingham Research Group, Inc.
Birmingham, Alabama, 35216, United States
Crest Clinical Trials, Inc.
Anaheim, California, 92804, United States
Southwesten Research, Inc.
Beverly Hills, California, 90210, United States
Southwestern Research Institute
Burbank, California, 91506, United States
University of California - San Diego - Dept of Psychiatry
San Diego, California, 92103, United States
Clinical Innovations
Santa Ana, California, 92705, United States
Stanford University Medical Center
Stanford, California, 94305, United States
Diablo Clinical Research, Inc.
Walnut Creek, California, 94598, United States
Alpine Clinical Research Center
Boulder, Colorado, 80304, United States
New Britain General Hospital
New Britain, Connecticut, 06050, United States
Florida Clinical Research Center
Bradenton, Florida, 34208, United States
ACT Clinical Research
DeLand, Florida, 32720, United States
University Clinical Research DeLand, Inc.
DeLand, Florida, 32720, United States
Sarkis Clinical Trials
Gainsville, Florida, 32607, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806, United States
Meridien Research
St. Petersburg, Florida, 33709, United States
Institute of Research in Psychiatry
Tampa, Florida, 33613, United States
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407, United States
Atlanta Institute of Medicine and Research
Marietta, Georgia, 30060, United States
Radiant Research
Boise, Idaho, 83704, United States
American Medical Research, Inc.
Oak Brook, Illinois, 60523, United States
Peak Medical Research, LLC
Owensboro, Kentucky, 42303, United States
New Orlean Medical Institute
Metairie, Louisiana, 70001, United States
Brentwood Research Institute
Shreveport, Louisiana, 71101, United States
Pharmasite Research, Inc.
Baltimore, Maryland, 21208, United States
McLean Hospital
Belmont, Massachusetts, 02478, United States
Pivotal Research Centers - Detroit
Royal Oak, Michigan, 48073, United States
MedClin Research
St Louis, Missouri, 63118, United States
CNS Research Institute (CRI)
Clementon, New Jersey, 08021, United States
ClinSearch, Inc.
Kenilworth, New Jersey, 07033, United States
Princeton Medical Institute
Princeton, New Jersey, 08540, United States
Social Psychiatry Research Institute
Brooklyn, New York, 11235, United States
Midwest Clinical Research Center
Dayton, Ohio, 45408, United States
Neurology and Neuroscience Center of Ohio
Toledo, Ohio, 43623, United States
IPS Research Company
Oklahoma City, Oklahoma, 73103, United States
Laureate Psychiatric Clinic and Hospital
Tulsa, Oklahoma, 74136, United States
Oregon Center for Clinical Investigations, Inc.
Eugene, Oregon, 97401, United States
Suburban Research Associates
Media, Pennsylvania, 19063, United States
CNS Research Institute
Philadelphia, Pennsylvania, 19149, United States
Southeast Health Consultants, LLC
Charleston, South Carolina, 29407, United States
CNS, Inc.
Memphis, Tennessee, 38119, United States
Clinical Research Associates, Inc.
Nashville, Tennessee, 37203, United States
FutureSearch Trials
Austin, Texas, 78756, United States
Research Across America
Dallas, Texas, 75234, United States
R/D Clinical Research, Inc.
Lake Jackson, Texas, 77566, United States
Lifetree Clinical Research
Salt Lake City, Utah, 84106, United States
Comprehensive Neuroscience of Northern Virginia
Falls Church, Virginia, 22041, United States
Dominion Clinical Research, Inc.
Midlothian, Virginia, 23112, United States
Northwest Clinical Research Center
Bellevue, Washington, 98004, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Grace Wang, MD Director Clinical Development & Medical Monitor
- Organization
- Jazz Pharmaceuticals, Inc.
Study Officials
- STUDY CHAIR
Murray Stein, MD
University of California, San Diego
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
November 29, 2004
First Posted
November 30, 2004
Study Start
November 1, 2004
Study Completion
December 1, 2005
Last Updated
October 3, 2014
Results First Posted
October 3, 2014
Record last verified: 2014-10