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Are quetiapine and lithium monotherapy effective and well-tolerated treatments for a major depressive episode in bipolar disorder?
802 adult (aged 18–65 years) outpatients with DSM-IV-defined bipolar disorder I or II (with or without rapid cycling; ≥4 episodes/year to ≤8 per year) who were experiencing an episode of depression (onset ≥4 weeks; duration ≤1 year), Hamilton Depression Rating Scale (HDRS) score ≥20 and an HDRS item 1 (depressed mood) score ≥2. See online notes for exclusion criteria.
Multicentre throughout Europe, Canada and Asia; August 2005 to May 2007.
300 mg/day of quetiapine, 600 mg/day of quetiapine, 600–1800 mg/day of lithium or placebo. Treatment randomisation was stratified by bipolar diagnosis (I or II) and within strata in a 2:2:1:1 ratio to quetiapine 300 mg/day, quetiapine 600 mg/day, lithium 600–1800 mg/day or placebo.
Primary outcome was improvement in depression measured as a change in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS) from baseline to week 8. Analysis of covariance was used with baseline MADRS total score as covariate, country as random effect and treatment and diagnosis strata as …
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