Objective: 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 (> or = 50% decrease from baseline in YMRS total score) and remission rate as defined using 3 criteria: YMRS total score < or = 12, YMRS total score < or = 12 + MADRS total score < or = 8, and YMRS total score < or = 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/day and 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 responded to quetiapine at Day 28, 88.3% were receiving 600-800mg/day. At Day 28 YMRS response rate was significantly greater with quetiapine than lithium (77.9% vs. 59.7%, p = 0.0132), and remission rates using the 3 criteria were significantly greater with quetiapine than lithium: YMRS total score < or = 12 (70.1% vs. 48.1%, p = 0.0071), YMRS < or = 12 + MADRS < or = 8 (70.1% vs. 48.1%; p = 0.0071), and YMRS < or = 8 (51.9% vs. 32.5%; p = 0.0147). Significant decreases were observed in PANSS, YMRS, and MADRS total scores for both groups. The most common AEs experienced by patients receiving quetiapine were constipation, dizziness, diarrhea, alanine aminotransferase increase, palpitations, aspartate aminotransferase increase, pharyngolaryngeal pain, upper respiratory tract infection and dry mouth. In patients receiving lithium, the most common AEs were nausea (16.9%), constipation (13.0%), vomiting (13.0%), nasopharyngitis (11.7%), dizziness (6.5%), diarrhea (6.5%), and upper respiratory tract infection (6.5%).
Conclusion: Quetiapine was shown to be clinically effective in patients with acute bipolar mania. There were side effects with quetiapine similar to those reported in other studies that included other ethnic populations of patients.