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
1255 participants
INTERVENTIONAL
2005-03-31
2007-07-31
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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Interventions
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quetiapine fumarate
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 18 years or older
* A diagnosis of Bipolar I Disorder
* Have a current manic, depressed or mixed episode
* Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
* Female patients of childbearing potential must be using a reliable method of contraception
Exclusion Criteria
* Substance or alcohol dependence at enrollment
* Unstable thyroid function
* Unstable Diabetes
* Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
* Use of an experimental drug within 30 days of enrollment
18 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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AstraZeneca CNS Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Cerritos, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Washington D.C., District of Columbia, United States
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Gainesville, Florida, United States
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Jacksonville, Florida, United States
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North Miami, Florida, United States
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Orlando, Florida, United States
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Atlanta, Georgia, United States
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Eagle, Idaho, United States
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Hoffman Estates, Illinois, United States
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Terre Haute, Indiana, United States
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Shreveport, Louisiana, United States
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Flowood, Mississippi, United States
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Saint Charles, Missouri, United States
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Las Vegas, Nevada, United States
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Clementon, New Jersey, United States
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Rochester, New York, United States
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Raleigh, North Carolina, United States
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Fargo, North Dakota, United States
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Portland, Oregon, United States
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Salem, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Memphis, Tennessee, United States
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Austin, Texas, United States
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Lake Jackson, Texas, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Kirkland, Washington, United States
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Seattle, Washington, United States
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Capital Federal, , Argentina
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Córdoba, , Argentina
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La Plata, , Argentina
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Lanús, , Argentina
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Mendoza, , Argentina
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Rosario, , Argentina
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Burgas, , Bulgaria
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Plovdiv, , Bulgaria
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Sofia, , Bulgaria
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Antioquia, , Colombia
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Barranquilla, , Colombia
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Bogotá, , Colombia
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Pereira, , Colombia
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Ahmedabad, , India
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Chennai, , India
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Jaipur, , India
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Kanpur, , India
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Lucknow, , India
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Mangalore, , India
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Manipal, , India
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Mumbai, , India
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New Delhi, , India
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Visakhapatnam, , India
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Kaunas, , Lithuania
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Klaipėda, , Lithuania
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Vilnius, , Lithuania
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Kuala Lumpur, , Malaysia
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Sarawak, , Malaysia
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León, , Mexico
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México, , Mexico
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San Luis Potosí City, , Mexico
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Lima, , Peru
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Cebu City, , Philippines
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Davao City, , Philippines
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Mandaluyong, , Philippines
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Manila, , Philippines
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Quezon City, , Philippines
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Arad, , Romania
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Brasov, , Romania
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Bucharest, , Romania
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Cluj-Napoca, , Romania
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Com Jebel, , Romania
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Craiova, , Romania
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Iași, , Romania
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Oradea, , Romania
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Piteşti, , Romania
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Sibiu, , Romania
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Târgovişte, , Romania
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Târgu Mureş, , Romania
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Kazan', , Russia
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Moscow, , Russia
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Saint Petersburg, , Russia
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Kaohsiung Hsien, , Taiwan
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Taipei, , Taiwan
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Taoyuan, , Taiwan
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Taoyuan Hsien, , Taiwan
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Bangkok, , Thailand
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Dnipro, , Ukraine
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Kharkiv, , Ukraine
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Kiev, , Ukraine
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Kyiv, , 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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Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.
Other Identifiers
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EUDRACT 2004-000915-25
Identifier Type: -
Identifier Source: secondary_id
D1447C00144
Identifier Type: -
Identifier Source: org_study_id