Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
672 participants
INTERVENTIONAL
2005-08-31
2007-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood)
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* History of non-response to an adequate treatment
* Patients who, in the investigator's judgment pose a current serious suicidal or homicidal risk
* Pregnancy or lactation
* Clinically relevant disease or clinical finding
18 Years
65 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
Kelowna, British Columbia, Canada
Research Site
Sydney, Nova Scotia, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Markham, Ontario, Canada
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Mississauga, Ontario, Canada
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Orléans, Ontario, Canada
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Waterloo, Ontario, Canada
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Montreal, Quebec, Canada
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Sherbrooke, Quebec, Canada
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Osijek, , Croatia
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Split, , Croatia
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Zadar, , Croatia
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Zagreb-Susedgrad, , Croatia
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Kohtla-Järve, , Estonia
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Tallinn, , Estonia
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Tartu, , Estonia
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Berlin, , Germany
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Würzburg, , Germany
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Solo, Java, Indonesia
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Jakarta, , Indonesia
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Lawang, , Indonesia
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Daugavpils, , Latvia
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Riga, , Latvia
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Kaunas, , Lithuania
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Šiauliai, , Lithuania
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Vilnius, , Lithuania
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Kuala Lumpur, , Malaysia
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Kuching Sarawak, , Malaysia
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Petaling Jaya, , Malaysia
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Brattvåg, , Norway
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Drammen, , Norway
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Fredrikstad, , Norway
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Mysen, , Norway
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Paradis, , Norway
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Davao City, , Philippines
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Iloilo City, , Philippines
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Mandaluyong, , Philippines
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Manila, , Philippines
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Gdynia, , Poland
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Leszno, , Poland
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Lodz, , Poland
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Skorzewo, , Poland
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Wroclaw, , Poland
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Zabrze, , Poland
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Arkhangelsk, , Russia
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Kazan', , Russia
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Lipetsk, , Russia
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Moscow, , Russia
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Nizhny Novgorod, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saratov, , Russia
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Smolensk, , Russia
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Stavropol, , Russia
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Tver', , Russia
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Yaroslavl, , Russia
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Belgrade, , Serbia
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Čačak, , Serbia
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Kragujevac, , Serbia
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Niš, , Serbia
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Valjevo, , Serbia
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Gyeonggi-do, , South Korea
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Seoul, , South Korea
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Changhua, , Taiwan
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Taipei, , Taiwan
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Luhansk, , Ukraine
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Lviv, , Ukraine
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Odesa, , Ukraine
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Simferopol, , Ukraine
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Vinnitsa, , Ukraine
Countries
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References
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Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. Epub 2010 Jan 26.
Other Identifiers
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EMBOLDEN I
Identifier Type: -
Identifier Source: secondary_id
D1447C00001
Identifier Type: -
Identifier Source: org_study_id
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