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The purpose of this study is to determine whether an experimental anti-anxiety medication is effective in the treatment of Generalized Anxiety Disorder.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| experimental anti-anxiety drug | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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 |
|---|---|---|---|---|---|---|
| Birmingham Research Group, Inc. | Birmingham | Alabama | 35216 | United States | ||
| Crest Clinical Trials, Inc. |
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| ID | Title | Description |
|---|---|---|
| FG000 | OROS Alprazolam | OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day |
| FG001 | IR Alprazolam |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 |
IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
| FG002 | Placebo | OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day. |
| Intent-to-Treat (ITT) |
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| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | OROS Alprazolam | |
| BG001 | IR Alprazolam | |
| BG002 | Placebo | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Age, Customized | Number | participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Least Squares Mean | Full Range | Units on a Scale | Baseline to week 8 |
|
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|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OROS Alprazolam | 6 | 171 | 140 | 171 | |||
| EG001 | IR Alprazolam | 1 | 176 | 141 | 176 | |||
| EG002 | Placebo | 0 | 160 | 118 | 160 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Duodenal Ulcer Perforation | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Ileitis | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Alcohol Poisoning | Injury, poisoning and procedural complications | MedDRA (7.1) | Non-systematic Assessment |
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| Post Procedural Haemorrhage | Injury, poisoning and procedural complications | MedDRA (7.1) | Non-systematic Assessment |
| |
| Intentional Self-Injury | Psychiatric disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Suicide Attempt | Psychiatric disorders | MedDRA (7.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Dry Mouth | Gastrointestinal disorders | MedDRA (7.1) | Non-systematic Assessment |
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| Fatigue | General disorders | MedDRA (7.1) | Non-systematic Assessment |
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| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (7.1) | Non-systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (7.1) | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (7.1) | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (7.1) | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (7.1) | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Grace Wang, MD Director Clinical Development & Medical Monitor | Jazz Pharmaceuticals, Inc. | 650 - 496 - 3777 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| 40 - < 65 years |
|
| >=65 years |
|
| Male |
|
| Mean Difference (Net) |
| -3.2 |
| 2-Sided |
| 95 |
| -5.0 |
| -1.4 |
| No |
| Superiority or Other |
| ANCOVA | 0.0015 | Mean Difference (Net) | 2.8 | 2-Sided | 95 | 1.1 | 4.5 | No | Superiority or Other |