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The purpose of this study is to determine the safety and efficacy of sustained-release quetiapine fumarate (Seroquel®) in the treatment of patients with Acute Bipolar Depression for 8 weeks.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate (Seroquel) SR | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in depression symptoms by final visit as measured by the MADRS total score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to final visit on the MADRS total score MADRS item scores, CGI-BP-S, CGI-BP-C |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Datto, MD | AstraZeneca | Study Director |
| Larisa Acevedo, Ph.D | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
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| Phoenix |
| Arizona |
| United States |
| Research Site | Scottsdale | Arizona | United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Cerritos | California | United States |
| Research Site | La Mesa | California | United States |
| Research Site | Los Angeles | California | United States |
| Research Site | Newport Beach | California | United States |
| Research Site | Northridge | California | United States |
| Research Site | Oceanside | California | United States |
| Research Site | Pico Rivera | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | Wildomar | California | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Bradenton | Florida | United States |
| Research Site | Fort Lauderdale | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Leesburg | Florida | United States |
| Research Site | Maitland | Florida | United States |
| Research Site | North Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Greenwood | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Farmington Hills | Michigan | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Cherry Hill | New Jersey | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Staten Island | New York | United States |
| Research Site | Beachwood | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Salem | Oregon | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | South Kirkland | Washington | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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