Response and remission rates in Chinese patients with bipolar mania treated for 4 weeks with either quetiapine or lithium: a randomized and double-blind study

ABSTRACTObjective: To assess the efficacy and tolerability of quetiapine in Chinese patients hospitalized with acute bipolar mania.Methods: This was a 4-week, multicenter, randomized, double-blind, lithium-controlled, parallel-group study. Secondary endpoints in the primary analysis were: response rate (≥ 50% decrease from baseline in YMRS total score) and remission rate as defined using 3 criteria: YMRS total score ≤ 12, YMRS total score ≤ 12 + MADRS total score ≤ 8, and YMRS total score ≤ 8. Other measures included: change from baseline at Day 28 in YMRS, PANSS, and MADRS total score. Adverse event (AE) data were collected throughout the study.Results: 73 (94.8%) quetiapine and 62 (80.5%) lithium patients completed the study. Mean (SD) quetiapine doses for the ITT population and responders were 648.2 (111.84) mg/dayand 637.5 (118.78) mg/day, respectively, while mean lithium concentrations for the ITT population and responders were 0.80 (0.28) mmol/L and 0.80 (0.22) mmol/L, respectively. Of patients who ...