This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. 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
TREATMENT
Masking
QUADRUPLE
Enrollment
1,255
Time from randomization to recurrence of a mood event
Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event
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Research Site
Cerritos, California, United States
Research Site
San Diego, California, United States
Research Site
Santa Ana, California, United States
Research Site
Washington D.C., District of Columbia, United States
Research Site
Gainesville, Florida, United States
Research Site
Jacksonville, Florida, United States
Research Site
North Miami, Florida, United States
Research Site
Orlando, Florida, United States
Research Site
Atlanta, Georgia, United States
Research Site
Eagle, Idaho, United States
...and 85 more locations