Quetiapine Fumarate (SEROQUEL) Compared to Placebo in the Treatment of Children & Adolescents With Bipolar I Mania
NCT ID: NCT00090311
Last Updated: 2013-01-04
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
220 participants
INTERVENTIONAL
2004-07-31
2006-07-31
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
Eligibility Criteria
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Inclusion Criteria
* Patient has a documented clinical diagnosis of Bipolar I mania
* Patient's parent or legal guardian will be able to accompany the patient at each scheduled study visit
Exclusion Criteria
* Patients with a known intolerance or lack of response to previous treatment with quetiapine
* Patients who have previously participated in this study
10 Years
17 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Principal Investigators
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Seroquel Medical Science Director, MD
Role: STUDY_DIRECTOR
AstraZeneca
Locations
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Research Site
Scottsdale, Arizona, United States
Research Site
Riverside, California, United States
Research Site
Sacramento, California, United States
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San Diego, California, United States
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Denver, Colorado, United States
Research Site
Alamonte, Florida, United States
Research Site
Jacksonville, Florida, United States
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Miami, Florida, United States
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Augusta, Georgia, United States
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Chicago, Illinois, United States
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Wichita, Kansas, United States
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New Orleans, Louisiana, United States
Research Site
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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Piscataway, New Jersey, United States
Research Site
Rochester, New York, United States
Research Site
Chapel Hill, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Lyndhurst, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Philadelphia, Pennsylvania, United States
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Madison, Tennessee, United States
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Austin, Texas, United States
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Houston, Texas, United States
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San Antonio, Texas, United States
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Richmond, Virginia, United States
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Virginia Beach, Virginia, United States
Research Site
Bellevue, Washington, United States
Research Site
Kirkland, Washington, United States
Research Site
Milwaukee, Wisconsin, United States
Countries
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References
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Pathak S, Findling RL, Earley WR, Acevedo LD, Stankowski J, Delbello MP. Efficacy and safety of quetiapine in children and adolescents with mania associated with bipolar I disorder: a 3-week, double-blind, placebo-controlled trial. J Clin Psychiatry. 2013 Jan;74(1):e100-9. doi: 10.4088/JCP.11m07424.
Other Identifiers
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D1441C00149
Identifier Type: -
Identifier Source: org_study_id
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