The purpose of this study is to determine whether quetiapine when used as adjunct to lithium or divalproex is safe and effective in the maintenance treatment of adult patients with Bipolar I Disorder. The study consists of enrollment and 2 phases, the Open-label treatment Phase and the Randomized treatment Phase. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
710
Evaluate the efficacy of quetiapine versus placebo when used as adjunct therapy to mood stabilizer in increasing time to recurrence of a mood event.
Evaluate the efficacy of quetiapine versus placebo when used as a adjunct therapy to mod stabilizer in increasing time to recurrence of a manic event
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Research Site
Birmingham, Alabama, United States
Research Site
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
...and 156 more locations