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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 Mania for 3 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 to final visit in the YMRS total score |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline to each visit in YMRS score and changes of YMRS subscores and changes in MADRS. |
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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 | Phoenix | Arizona | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22054797 | Derived | Cutler AJ, Datto C, Nordenhem A, Minkwitz M, Acevedo L, Darko D. Extended-release quetiapine as monotherapy for the treatment of adults with acute mania: a randomized, double-blind, 3-week trial. Clin Ther. 2011 Nov;33(11):1643-58. doi: 10.1016/j.clinthera.2011.10.002. Epub 2011 Nov 4. |
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| Little Rock |
| Arkansas |
| United States |
| Research Site | Cerritos | California | United States |
| Research Site | Garden Grove | 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 | Santa Ana | California | United States |
| Research Site | Torrance | California | United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Washington D.C. | District of Columbia | United States |
| Research Site | Aventura | Florida | United States |
| Research Site | EAST Bradenton | Florida | United States |
| Research Sitew | Fort Lauderdale | Florida | United States |
| Research Site | Hollywood | Florida | United States |
| Research Site | Leesburg | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Naperville | Illinois | United States |
| Research Site | OAK Brook Terrace | Illinois | United States |
| Research Site | Greenwood | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Newton | Kansas | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Kenilworth | New Jersey | United States |
| Research Site | Willingboro | New Jersey | United States |
| Research Site | Elmsford | New York | United States |
| Research Site | Holliswood | New York | United States |
| Research Site | Durham | North Carolina | United States |
| Research Site | Beachwood | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Moon Township | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Charleston | South Carolina | United States |
| Research Site | Memphis | Tennessee | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | Austin | Texas | United States |
| Research Site | DeSoto | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Irving | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | Arlington | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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