Anxiety Disorder Clinical Trial
Official title:
A Double-Blind, Placebo Controlled Trial of an Experimental Medication For the Treatment of Generalized Anxiety Disorder
| Verified date | October 2014 |
| Source | Jazz Pharmaceuticals |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
| Status | Completed |
| Enrollment | 511 |
| Est. completion date | December 2005 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 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. Exclusion Criteria: - No other primary psychiatric diagnosis besides GAD. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Crest Clinical Trials, Inc. | Anaheim | California |
| United States | FutureSearch Trials | Austin | Texas |
| United States | Pharmasite Research, Inc. | Baltimore | Maryland |
| United States | Northwest Clinical Research Center | Bellevue | Washington |
| United States | McLean Hospital | Belmont | Massachusetts |
| United States | Southwesten Research, Inc. | Beverly Hills | California |
| United States | Birmingham Research Group, Inc. | Birmingham | Alabama |
| United States | Radiant Research | Boise | Idaho |
| United States | Alpine Clinical Research Center | Boulder | Colorado |
| United States | Florida Clinical Research Center | Bradenton | Florida |
| United States | Social Psychiatry Research Institute | Brooklyn | New York |
| United States | Southwestern Research Institute | Burbank | California |
| United States | Southeast Health Consultants, LLC | Charleston | South Carolina |
| United States | CNS Research Institute (CRI) | Clementon | New Jersey |
| United States | Research Across America | Dallas | Texas |
| United States | Midwest Clinical Research Center | Dayton | Ohio |
| United States | ACT Clinical Research | DeLand | Florida |
| United States | University Clinical Research DeLand, Inc. | DeLand | Florida |
| United States | Oregon Center for Clinical Investigations, Inc. | Eugene | Oregon |
| United States | Comprehensive Neuroscience of Northern Virginia | Falls Church | Virginia |
| United States | Sarkis Clinical Trials | Gainsville | Florida |
| United States | Clinical Neuroscience Solutions, Inc. | Jacksonville | Florida |
| United States | ClinSearch, Inc. | Kenilworth | New Jersey |
| United States | R/D Clinical Research, Inc. | Lake Jackson | Texas |
| United States | Atlanta Institute of Medicine and Research | Marietta | Georgia |
| United States | Suburban Research Associates | Media | Pennsylvania |
| United States | CNS, Inc. | Memphis | Tennessee |
| United States | New Orlean Medical Institute | Metairie | Louisiana |
| United States | Dominion Clinical Research, Inc. | Midlothian, | Virginia |
| United States | Clinical Research Associates, Inc. | Nashville | Tennessee |
| United States | New Britain General Hospital | New Britain | Connecticut |
| United States | American Medical Research, Inc. | Oak Brook | Illinois |
| United States | IPS Research Company | Oklahoma City | Oklahoma |
| United States | Clinical Neuroscience Solutions, Inc. | Orlando | Florida |
| United States | Peak Medical Research, LLC | Owensboro | Kentucky |
| United States | CNS Research Institute | Philadelphia | Pennsylvania |
| United States | Princeton Medical Institute | Princeton | New Jersey |
| United States | Pivotal Research Centers - Detroit | Royal Oak | Michigan |
| United States | Lifetree Clinical Research | Salt Lake City | Utah |
| United States | University of California - San Diego - Dept of Psychiatry | San Diego | California |
| United States | Clinical Innovations | Santa Ana | California |
| United States | Brentwood Research Institute | Shreveport | Louisiana |
| United States | MedClin Research | St. Louis | Missouri |
| United States | Meridien Research | St. Petersburg | Florida |
| United States | Stanford University Medical Center | Stanford | California |
| United States | Institute of Research in Psychiatry | Tampa | Florida |
| United States | Neurology and Neuroscience Center of Ohio | Toledo | Ohio |
| United States | Laureate Psychiatric Clinic and Hospital | Tulsa | Oklahoma |
| United States | Diablo Clinical Research, Inc. | Walnut Creek | California |
| United States | Janus Center for Psychiatric Research | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| Jazz Pharmaceuticals |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
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