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The study is to assess the performance characteristics of a new measure to assess onset of efficacy in a GAD patient population.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| lorazepam | Active Comparator |
| |
| placebo | Placebo Comparator |
| |
| paroxetine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorazepam | Drug | 1.0 mg p.o. three times a day for three days, then 1.5mg p.o. three times a day for 25 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average change from baseline over the first 6 days of treatment assessment (Study Days 2 through 7) on the Daily Assessment of Symptoms - Anxiety (DAS-A) questionnaire. | baseline, days 2 through 7 |
| Measure | Description | Time Frame |
|---|---|---|
| CGIC at endpoint (LOCF) | endpoint | |
| PGIC at endpoint (LOCF) | endpoint | |
| Q-LES-Q change from baseline to endpoint (LOCF) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Glendale | California | 91206 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| placebo | Drug | placebo p.o. t.i.d. for 28 days; placebo matching lorazepam and paroxetine |
|
| paroxetine | Drug | 20mg p.o. daily for 28 days; and matching placebo twice a day to maintain blind |
|
|
| baseline, endpoint |
| SF-36v2 Mental Health change from baseline to endpoint (LOCF) | baseline, endpoint |
| HADS-A change from baseline to endpoint (LOCF) | baseline, endpoint |
| HADS-D change from baseline to endpoint (LOCF) | baseline, endpoint |
| Change from baseline to endpoint (Weeks 1, 2, 4, and 5) in the HAM-A total score. | baseline and weeks 1,2,4, and 5 |
| Change from baseline to daily time point (Study Days 2 through 7) on the DAS-A. | baseline and days 2 through 7 |
| DAS-A change from baseline to endpoint (LOCF) | baseline to endpoint |
| DAS-A 30% and 50% improvement at endpoint; | endpoint |
| DAS-A 30% sustained improvement beginning at week 1 | baseline, week1, 2,4, |
| HAM-A 30% sustained improvement beginning at week 1 | baseline, weeks 1,2,4 |
| HAM-A 30% and 50% improvement at endpoint | endpoint |
| GA-VAS average change from baseline over the first 6 days | baseline, days 2-7 |
| Change from baseline to daily time point on the GA-VAS(study days 2 through 7) | baseline, days 2-7 |
| GA-VAS change from baseline to endpoint | aseline, endpoint |
| GA-VAS sustained 30% improvement beginning at week 1 | baseline, weeks 1,2,4 |
| GA-VAS 30% and 50% improvement at endpoint | endpoint |
| Northridge |
| California |
| 91406 |
| United States |
| Pfizer Investigational Site | Orange | California | 92868 | United States |
| Pfizer Investigational Site | San Diego | California | 92105 | United States |
| Pfizer Investigational Site | Sherman Oaks | California | 91403 | United States |
| Pfizer Investigational Site | Van Nuys | California | 91406 | United States |
| Pfizer Investigational Site | Casselberry | Florida | 32707 | United States |
| Pfizer Investigational Site | Orlando | Florida | 32806 | United States |
| Pfizer Investigational Site | Atlanta | Georgia | 30328 | United States |
| Pfizer Investigational Site | Marietta | Georgia | 30060 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66209 | United States |
| Pfizer Investigational Site | Overland Park | Kansas | 66211 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87102 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87104 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45267-0559 | United States |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| D017374 | Paroxetine |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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