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The purpose of the study is to assess the safety and effectiveness of the experimental drug, a benzodiazepine drug, in long-term use and the effects on quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with anxiety disorder.
This trial is a long-term, open label, safety and efficacy study of an experimental medication in adults with Generalized Anxiety Disorder (GAD). To enroll in this study, investigators and patients must have first participated in Jazz Pharmaceuticals, Inc. Protocol 04-001-01. The study is designed for four stages that should last a total of 37 weeks.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| a benzodiazepine drug | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment (over 37 additional weeks following the double-blind study) of the safety of the experimental drug in long-term use in subjects with Generalized Anxiety Disorder (GAD) |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the long-term efficacy of open-label study of the experimental drug in subjects with GAD | ||
| Assessment of the long-term effects on the quality of life, social and occupational functioning, sleep, and daytime sedation in subjects with GAD |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Murray Stein, MD | University of California, San Diego | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Clinical Research Center | Bradenton | Florida | 34208 | United States | ||
| Clinical Neuroscience Solutions, Inc. |
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| Jacksonville |
| Florida |
| 32216 |
| United States |
| Meridien Research | St. Petersburg | Florida | 33709 | United States |
| CNS Research Institute (CRI) | Clementon | New Jersey | 08021 | United States |
| Midwest Clinical Research Center | Dayton | Ohio | 45408 | United States |
| Neurology and NeuroscienceCenter of Ohio | Toledo | Ohio | 43623 | United States |
| IPS Research Company | Oklahoma City | Oklahoma | 73103 | United States |
| Oregon Center for Clinical Research, Inc. | Eugene | Oregon | 97401 | United States |
| Suburban Research Associates | Media | Pennsylvania | 19603 | United States |
| CNS Research Institute (CRI) | Philadelphia | Pennsylvania | 19149 | United States |
| Future Search Trials | Austin | Texas | 78756 | United States |
| Comprehensive Neuroscience of Northern Virginia | Falls Church | Virginia | 22041 | United States |
| Northwest Clinical Research Center | Bellevue | Washington | 98004 | United States |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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