Quetiapine in bipolar depression Authors: Calabrese JR, et al. Title: Double-blind, placebo-controlled study of quetiapine in bipolar depression. Reference:APA 2004, New Research Presentation. Purpose: To evaluate the efficacy and safety of quetiapine in the acute treatment of bipolar depression. Study design: Randomized, double-blinded, placebo-controlled trial. Follow up: 8 weeks. Patients: 511 patients (170 quetiapine 600 mg/day, 172 quetiapine 300 mg/day, 169 placebo). Treatment: Quetiapine 300 or 600 mg/day (once daily at bedtime). Results: A significant improvement in MADRS score (ITT, LOCF) was observed in patients receiving either dose of quetiapine compared with placebo, which begun at week 1 and was sustained throughout the remainder of the trial. Core depressive symptoms were also significantly reduced in patients receiving quetiapine compared with placebo. The most frequent side effects were a dry mouth (41–44%), sedation (30–32%), somnolence (24–27%), and dizziness (17–23%). Weight gain was +1.6 kg for quetiapine 600mg, +0.4 kg for quetiapine 300mg, and +0.1 kg for placebo.
