Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
193 participants
INTERVENTIONAL
2009-01-31
2010-11-30
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
QUADRUPLE
Study Groups
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Quetiapine XR
Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
Placebo
Placebo
Oral treatment once daily in the evening
Interventions
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Quetiapine XR
Oral treatment with 150 up to 300 mg/day once daily in the evening
Placebo
Oral treatment once daily in the evening
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have a documented clinical diagnosis for bipolar I or bipolar II disorder, and including current episode depressed.
* Patients are required to be in outpatient status at the enrollment and randomization visits and believed likely to remain an outpatient for the duration of the study.
* Patients must be able to swallow the study medication tablets.
Exclusion Criteria
* Patient can not have a history of non-response to an adequate treatment to more than 2 antidepressants during the current episode.
* The patient must not have received electroconvulsive therapy (ECT) within 30 days before participating in the study.
* Patients who in your doctors judgement pose a current suicidal or homicidal risk.
10 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Castiglione
Role: STUDY_DIRECTOR
AstraZeneca
Robert L. Findling
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Case Medical CenterCase Western Reserve University School of Medicine
Locations
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Research Site
Dothan, Alabama, United States
Research Site
Scottsdale, Arizona, United States
Research Site
Little Rock, Arkansas, United States
Research Site
Escondido, California, United States
Research Site
Bradenton, Florida, United States
Research Site
Gainsville, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
Tampa, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Smyrna, Georgia, United States
Research Site
Eagle, Idaho, United States
Research Site
Hoffman Estates, Illinois, United States
Research Site
Terre Haute, Indiana, United States
Research Site
Overland Park, Kansas, United States
Research Site
Wichita, Kansas, United States
Research Site
Clinton Township, Michigan, United States
Research Site
Minneapolis, Minnesota, United States
Research Site
Flowood, Mississippi, United States
Research Site
St Louis, Missouri, United States
Research Site
Lincoln, Nebraska, United States
Research Site
Rochester, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Cleveland, Ohio, United States
Research Site
Mason, Ohio, United States
Research Site
Oklahoma City, Oklahoma, United States
Research Site
Charleston, South Carolina, United States
Research Site
Memphis, Tennessee, United States
Research Site
Wharton, Texas, United States
Research Site
Virginia Beach, Virginia, United States
Research Site
Bothell, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Research Site
Bogota D.c, Cundinamarca, Colombia
Research Site
Bello, , Colombia
Research Site
Bogotá, , Colombia
Research Site
Medellín, , Colombia
Research Site
Vijaywada, Andh Prad, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Vadodara, Gujarat, India
Research Site
Varanasi, Uttar Prad, India
Research Site
León, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Belgrade, , Serbia
Research Site
Novi Sad, , Serbia
Research Site
Pretoria, Gauteng, South Africa
Research Site
Cape Town, W Cape, South Africa
Research Site
Taoyuan District, Taiwan, Taiwan
Research Site
Changhua, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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References
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Findling RL, Pathak S, Earley WR, Liu S, DelBello MP. Efficacy and safety of extended-release quetiapine fumarate in youth with bipolar depression: an 8 week, double-blind, placebo-controlled trial. J Child Adolesc Psychopharmacol. 2014 Aug;24(6):325-35. doi: 10.1089/cap.2013.0105. Epub 2014 Jun 23.
Related Links
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CSR-D144AC00001.pdf
D144AC00001\_Redacted\_Study\_Protocol
Other Identifiers
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D144AC00001
Identifier Type: -
Identifier Source: org_study_id
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