Efficacy & Safety of Seroquel Plus Mood Stabilizer in the Maintenance of Bipolar I Disorder
NCT ID: NCT00107731
Last Updated: 2009-03-25
Study Results
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Basic Information
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COMPLETED
PHASE3
710 participants
INTERVENTIONAL
2004-04-30
2006-10-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Interventions
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quetiapine fumarate
lithium
divalproex
Eligibility Criteria
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Inclusion Criteria
* At least 1 manic, depressed, or mixed episode in the 2 years prior to the index episode.
* Able to understand and comply with the requirements of the study.
Exclusion Criteria
* Known intolerance or lack of response to quetiapine fumarate or to the assigned mood stabilizer, as judged by the investigator.
* Previously randomized into this study or D1447C00126
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Birmingham, Alabama, United States
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Beverly Hills, California, United States
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Chula Vista, California, United States
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Redlands, California, United States
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San Francisco, California, United States
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Santa Ana, California, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Sarasota, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Granite City, Illinois, United States
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Libertyville, Illinois, United States
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Schaumburg, Illinois, United States
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Wichita, Kansas, United States
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Metairie, Louisiana, United States
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Glen Burnie, Maryland, United States
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Kalamazoo, Michigan, United States
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Saint Charles, Missouri, United States
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St Louis, Missouri, United States
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Brooklyn, New York, United States
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Olean, New York, United States
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Rochester, New York, United States
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Morganton, North Carolina, United States
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Raleigh, North Carolina, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Havertown, Pennsylvania, United States
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Media, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Conroe, Texas, United States
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Houston, Texas, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Milwaukee, Wisconsin, United States
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Greenwich, New South Wales, Australia
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Brisbane, Queensland, Australia
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Everton Park, Queensland, Australia
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Southport, Queensland, Australia
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Glenside, South Australia, Australia
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Box Hill, Victoria, Australia
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Dandenong, Victoria, Australia
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Epping, Victoria, Australia
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Richmond, Victoria, Australia
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Assebroek, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Kortenberg, , Belgium
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Manage, , Belgium
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St-Denijs-Westrem, , Belgium
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Waregem, , Belgium
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Kardzhali, , Bulgaria
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Rousse, , Bulgaria
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Jeseník, , Czechia
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Litomolice, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Pterova, , Czechia
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Espoo, , Finland
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Harjavalta, , Finland
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Helsinki, , Finland
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Kellokoski, , Finland
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Seinäjoki, , Finland
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Besançon, , France
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Bourg-en-Bresse, , France
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La Rochelle, , France
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Marseille, , France
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Montpellier, , France
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Nîmes, , France
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Paris, , France
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Strasbourg, , France
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Toulouse, , France
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Augsburg, , Germany
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Berlin, , Germany
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Cologne, , Germany
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Heidelberg, , Germany
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Homburg, , Germany
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München, , Germany
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Regensburg, , Germany
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Saarbrücken, , Germany
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Budapest, , Hungary
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Füzesabony, , Hungary
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Győr, , Hungary
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Kecskemét, , Hungary
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Kistarcsa, , Hungary
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Pécs, , Hungary
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Bari, , Italy
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Bergamo, , Italy
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Brescia, , Italy
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Cagliari, , Italy
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Civitanova Marche, , Italy
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Florence, , Italy
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Genova, , Italy
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La Spezia, , Italy
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Milan, , Italy
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Napoli, , Italy
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Padua, , Italy
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Pisa, , Italy
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Roma, , Italy
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Siena, , Italy
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Trieste, , Italy
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Bergen, , Norway
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Bodø, , Norway
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Bryne, , Norway
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Namsos, , Norway
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Oslo, , Norway
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Ottestad, , Norway
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Skien, , Norway
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Choroszcz, , Poland
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Gdansk, , Poland
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Gorlice, , Poland
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Janów Lubelski, , Poland
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Krakow, , Poland
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Lipno, , Poland
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Lodz, , Poland
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Lublin, , Poland
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Nowy Targ, , Poland
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Poznan, , Poland
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Starogard Gdański, , Poland
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Szczecin, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Zubki, , Poland
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Moscow, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Bloemfontein, , South Africa
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Durban, , South Africa
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Johannesburg, , South Africa
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Krugersdorp, , South Africa
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Pretoria, , South Africa
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Barcelona, Barcelona, Spain
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Terrassa, Barcelona, Spain
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Puerto Real, Cádiz, Spain
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Granada, Granada, Spain
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Madrid, Madrid, Spain
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Oviedo, Oviedo, Spain
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Langreo, Principality of Asturias, Spain
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Oviedo, Principality of Asturias, Spain
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Seville, Sevilla, Spain
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Bilbao, , Spain
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Guadalajara, , Spain
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Santiago de Compostela, , Spain
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Vigo, , Spain
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Falköping, , Sweden
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Linköping, , Sweden
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Ludvika, , Sweden
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Sollentuna, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Birmingham, , United Kingdom
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London, , United Kingdom
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Oxford, , United Kingdom
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Runcorn, , United Kingdom
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Ryhope, , United Kingdom
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Surbiton, , United Kingdom
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Welwyn Garden City, , United Kingdom
Countries
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References
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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.
Other Identifiers
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D1447C00126
Identifier Type: -
Identifier Source: org_study_id
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