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The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase.
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 |
|---|---|---|---|---|
| Seroquel®, quetiapine fumarate (atypical antipsychotic) | Drug | |||
| lithium (mood stabilizer) | Drug | |||
| divalproex (mood stabilizer) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event. |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event. |
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Inclusion Criteria:
Open-Label
Exclusion Criteria:
Open-Label
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca Seroquel Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23761037 | Derived | Suppes T, Vieta E, Gustafsson U, Ekholm B. Maintenance treatment with quetiapine when combined with either lithium or divalproex in bipolar I disorder: analysis of two large randomized, placebo-controlled trials. Depress Anxiety. 2013 Nov;30(11):1089-98. doi: 10.1002/da.22136. Epub 2013 Jun 12. |
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| Scottsdale |
| Arizona |
| United States |
| Research Site | Little Rock | Arkansas | United States |
| Research Site | Anaheim | California | United States |
| Research Site | Cerritos | California | United States |
| Research Site | Chula Vista | California | United States |
| Research Site | Culver City | California | United States |
| Research Site | Garden Grove | California | United States |
| Research Site | La Mesa | California | United States |
| Research Site | Oceanside | California | United States |
| Research Site | Orange | California | United States |
| Research Site | Pico Rivera | California | United States |
| Research Site | Riverside | California | United States |
| Research Site | Rosemead | California | United States |
| Research Site | San Diego | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Farmington | Connecticut | United States |
| Research Site | New Britain | Connecticut | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Orlando | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Decatur | Georgia | United States |
| Research Site | Marietta | Georgia | United States |
| Research Site | Smyrna | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Hoffman Estates | Illinois | United States |
| Research Site | Joliet | Illinois | United States |
| Research Site | Evansville | Indiana | United States |
| Research Site | Greenwood | Indiana | United States |
| Research Site | Indianapolis | Indiana | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Florence | Kentucky | United States |
| Research Site | Lake Charles | Louisiana | United States |
| Research Site | New Orleans | Louisiana | United States |
| Research Site | Shreveport | Louisiana | United States |
| Research Site | Baltimore | Maryland | United States |
| Research Site | Rockville | Maryland | United States |
| Research Site | Pittsfield | Massachusetts | United States |
| Research Site | New Baltimore | Michigan | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Clementon | New Jersey | United States |
| Research Site | Moorestown | New Jersey | United States |
| Research Site | West Caldwell | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | The Bronx | New York | United States |
| Research Site | Butner | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Beachwood | Ohio | United States |
| Research Site | Cincinnati | Ohio | United States |
| Research Site | Dayton | Ohio | United States |
| Research Site | Medina | Ohio | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Tulsa | Oklahoma | United States |
| Research Site | Eugene | Oregon | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Emmaus | Pennsylvania | 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 | Austin | Texas | United States |
| Research Site | Dallas | 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 | Wichita Falls | Texas | United States |
| Research Site | Charlottesville | Virginia | United States |
| Research Site | Falls Church | Virginia | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Virginia Beach | Virginia | United States |
| Research Site | Bellevue | Washington | United States |
| Research Site | Kirkland | Washington | United States |
| Research Site | Morgantown | West Virginia | United States |
| Research Site | Edmonton | Alberta | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Victoria | British Columbia | Canada |
| Research Site | Winnipeg | Manitoba | Canada |
| Research Site | Halifax | Nova Scotia | Canada |
| Research Site | Hamilton | Ontario | Canada |
| Research Site | Kingston | Ontario | Canada |
| Research Site | Markham | Ontario | Canada |
| Research Site | Mississauga | Ontario | Canada |
| Research Site | Oshawa | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Québec | Quebec | Canada |
| 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 |
| D008094 | Lithium |
| D014635 | Valproic Acid |
| 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 |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |
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