Efficacy of Quetiapine Monotherapy for the Treatment of Depressive Episodes in Bipolar I Disorder: A Post Hoc Analysis of Combined Results From 2 Double-Blind, Randomized, Placebo-Controlled Studies
J Clin Psychiatry 2008;69(5):769-782
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Objective: To investigate the efficacy and tolerability of
quetiapine monotherapy for the treatment of major depressive episodes in
patients with bipolar I disorder, as a post hoc analysis of data from 2 large
studies, the BipOLar DEpRession (BOLDER) I and II studies, which investigated
the overall efficacy of quetiapine in both bipolar I and II disorder.
Method: A combined cohort of patients with depressive episodes
in bipolar I disorder (DSM-IV criteria) (N = 694) from 2 nearly identical
double-blind, randomized, placebo-controlled studies that each randomly
assigned patients with bipolar I and II disorder to 8 weeks of treatment with
quetiapine 300 or 600 mg/day or placebo was analyzed. The primary efficacy
measure was change from baseline to end of treatment (week 8) in the
Montgomery-Asberg Depression Rating Scale (MADRS) total scores.
Results: In the combined cohort of patients with depressive
episodes in bipolar I disorder from 2 studies, there were significantly greater
clinical improvements in mean MADRS total scores among patients who received
quetiapine compared with placebo from baseline to week 1 and through week 8 (at
week 8: quetiapine 300 mg/day = -19.4; 600 mg/day = -19.6; placebo = -12.6; p <
.001 for each dose), providing effect sizes of 0.78 and 0.80, respectively.
Changes in MADRS were unrelated to reports of sedation and somnolence. The most
common adverse events (AEs) with quetiapine were dry mouth, somnolence,
sedation, dizziness, and constipation. Rates of withdrawal because of these AEs
were relatively low.
Conclusions: Quetiapine monotherapy (300 and 600 mg/day) is
more effective than placebo and generally well tolerated for the treatment of
depressive episodes in patients with bipolar I disorder.