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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 |
|---|---|---|---|---|
| quetiapine fumarate | Drug | |||
| lithium | Drug | |||
| divalproex | 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:
Exclusion Criteria:
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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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| Beverly Hills |
| California |
| United States |
| Research Site | Chula Vista | California | United States |
| Research Site | Redlands | California | United States |
| Research Site | San Francisco | California | United States |
| Research Site | Santa Ana | California | United States |
| Research Site | Gainesville | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Miami | Florida | United States |
| Research Site | Sarasota | Florida | United States |
| Research Site | Tampa | Florida | United States |
| Research Site | Winter Park | Florida | United States |
| Research Site | Granite City | Illinois | United States |
| Research Site | Libertyville | Illinois | United States |
| Research Site | Schaumburg | Illinois | United States |
| Research Site | Wichita | Kansas | United States |
| Research Site | Metairie | Louisiana | United States |
| Research Site | Glen Burnie | Maryland | United States |
| Research Site | Kalamazoo | Michigan | United States |
| Research Site | Saint Charles | Missouri | United States |
| Research Site | St Louis | Missouri | United States |
| Research Site | Brooklyn | New York | United States |
| Research Site | Olean | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Morganton | North Carolina | United States |
| Research Site | Raleigh | North Carolina | United States |
| Research Site | Oklahoma City | Oklahoma | United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Havertown | Pennsylvania | United States |
| Research Site | Media | Pennsylvania | United States |
| Research Site | Philadelphia | Pennsylvania | United States |
| Research Site | Conroe | Texas | United States |
| Research Site | Houston | Texas | United States |
| Research Site | Richmond | Virginia | United States |
| Research Site | Seattle | Washington | United States |
| Research Site | Milwaukee | Wisconsin | United States |
| Research Site | Greenwich | New South Wales | Australia |
| Research Site | Brisbane | Queensland | Australia |
| Research Site | Everton Park | Queensland | Australia |
| Research Site | Southport | Queensland | Australia |
| Research Site | Glenside | South Australia | Australia |
| Research Site | Box Hill | Victoria | Australia |
| Research Site | Dandenong | Victoria | Australia |
| Research Site | Epping | Victoria | Australia |
| Research Site | Richmond | Victoria | Australia |
| Research Site | Assebroek | Belgium |
| Research Site | Brussels | Belgium |
| Research Site | Ghent | Belgium |
| Research Site | Kortenberg | Belgium |
| Research Site | Manage | Belgium |
| Research Site | St-Denijs-Westrem | Belgium |
| Research Site | Waregem | Belgium |
| Research Site | Kardzhali | Bulgaria |
| Research Site | Rousse | Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Varna | Bulgaria |
| Research Site | Jeseník | Czechia |
| Research Site | Litomolice | Czechia |
| Research Site | Olomouc | Czechia |
| Research Site | Prague | Czechia |
| Research Site | Pterova | Czechia |
| Research Site | Espoo | Finland |
| Research Site | Harjavalta | Finland |
| Research Site | Helsinki | Finland |
| Research Site | Kellokoski | Finland |
| Research Site | Seinäjoki | Finland |
| Research Site | Besançon | France |
| Research Site | Bourg-en-Bresse | France |
| Research Site | La Rochelle | France |
| Research Site | Marseille | France |
| Research Site | Montpellier | France |
| Research Site | Nîmes | France |
| Research Site | Paris | France |
| Research Site | Strasbourg | France |
| Research Site | Toulouse | France |
| Research Site | Augsburg | Germany |
| Research Site | Berlin | Germany |
| Research Site | Cologne | Germany |
| Research Site | Heidelberg | Germany |
| Research Site | Homburg | Germany |
| Research Site | München | Germany |
| Research Site | Regensburg | Germany |
| Research Site | Saarbrücken | Germany |
| Research Site | Budapest | Hungary |
| Research Site | Füzesabony | Hungary |
| Research Site | Győr | Hungary |
| Research Site | Kecskemét | Hungary |
| Research Site | Kistarcsa | Hungary |
| Research Site | Pécs | Hungary |
| Research Site | Bari | Italy |
| Research Site | Bergamo | Italy |
| Research Site | Brescia | Italy |
| Research Site | Cagliari | Italy |
| Research Site | Civitanova Marche | Italy |
| Research Site | Florence | Italy |
| Research Site | Genova | Italy |
| Research Site | La Spezia | Italy |
| Research Site | Milan | Italy |
| Research Site | Naples | Italy |
| Research Site | Padova | Italy |
| Research Site | Pisa | Italy |
| Research Site | Roma | Italy |
| Research Site | Siena | Italy |
| Research Site | Trieste | Italy |
| Research Site | Bergen | Norway |
| Research Site | Bodø | Norway |
| Research Site | Bryne | Norway |
| Research Site | Namsos | Norway |
| Research Site | Oslo | Norway |
| Research Site | Ottestad | Norway |
| Research Site | Skien | Norway |
| Research Site | Bialystok | Poland |
| Research Site | Bydgoszcz | Poland |
| Research Site | Choroszcz | Poland |
| Research Site | Gdansk | Poland |
| Research Site | Gorlice | Poland |
| Research Site | Janów Lubelski | Poland |
| Research Site | Krakow | Poland |
| Research Site | Lipno | Poland |
| Research Site | Lodz | Poland |
| Research Site | Lublin | Poland |
| Research Site | Nowy Targ | Poland |
| Research Site | Poznan | Poland |
| Research Site | Starogard Gdański | Poland |
| Research Site | Szczecin | Poland |
| Research Site | Torun | Poland |
| Research Site | Warsaw | Poland |
| Research Site | Zubki | Poland |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Saratov | Russia |
| Research Site | Bloemfontein | South Africa |
| Research Site | Durban | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Krugersdorp | South Africa |
| Research Site | Pretoria | South Africa |
| Research Site | Barcelona | Barcelona | Spain |
| Research Site | Terrassa | Barcelona | Spain |
| Research Site | Puerto Real | Cádiz | Spain |
| Research Site | Granada | Granada | Spain |
| Research Site | Madrid | Madrid | Spain |
| Research Site | Oviedo | Oviedo | Spain |
| Research Site | Langreo | Principality of Asturias | Spain |
| Research Site | Oviedo | Principality of Asturias | Spain |
| Research Site | Seville | Sevilla | Spain |
| Research Site | Bilbao | Spain |
| Research Site | Guadalajara | Spain |
| Research Site | Santiago de Compostela | Spain |
| Research Site | Vigo | Spain |
| Research Site | Falköping | Sweden |
| Research Site | Linköping | Sweden |
| Research Site | Ludvika | Sweden |
| Research Site | Sollentuna | Sweden |
| Research Site | Stockholm | Sweden |
| Research Site | Sundsvall | Sweden |
| Research Site | Adana | Turkey (Türkiye) |
| Research Site | Ankara | Turkey (Türkiye) |
| Research Site | Istanbul | Turkey (Türkiye) |
| Research Site | Izmir | Turkey (Türkiye) |
| Research Site | Birmingham | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Oxford | United Kingdom |
| Research Site | Runcorn | United Kingdom |
| Research Site | Ryhope | United Kingdom |
| Research Site | Surbiton | United Kingdom |
| Research Site | Welwyn Garden City | United Kingdom |
| 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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