| Summary: | Abstract Aim This systematic review and random‐effect model, network meta‐analysis of the phase 3 trials in Japan assessed the efficacy and safety profile of lurasidone compared with olanzapine and quetiapine extended‐release (QUE‐XR) for the treatment of bipolar depression. Methods The study included double‐blind, randomized, placebo‐controlled, phase 3 trials in Japan that included patients with bipolar depression. Outcomes included response rate (primary), remission rate (secondary), improvement of Montgomery‐Åsberg Depression Rating Scale (MADRS) total score, discontinuation rates, and incidence of individual adverse events. Results Three studies were included (n = 1223). Lurasidone and olanzapine but not QUE‐XR were superior to placebo in response rate [risk ratio (95% credible interval): lurasidone = 0.78 (0.66, 0.92); olanzapine = 0.84 (0.71, 0.99); QUE‐XR = 0.87 (0.73, 1.03)]. Lurasidone, olanzapine and QUE‐XR were superior to placebo in remission rate [lurasidone = 0.90 (0.83, 0.98); olanzapine = 0.87 (0.77, 0.99); QUE‐XR = 0.84 (0.73, 0.98)] and the improvement of MADRS total score. There were not differences in discontinuation rates between each antipsychotic and placebo. Compared with placebo, lurasidone was higher incidence of akathisia, and increased body weight and blood prolactin level; olanzapine was higher incidence of somnolence and ≥7% weight gain, and increased body weight, blood total cholesterol level, blood LDL cholesterol level, and blood triglyceride levels; QUE‐XR was higher incidence of extrapyramidal symptoms, akathisia, somnolence, dry mouth, constipation and ≥7% weight gain, and increased body weight, blood total cholesterol level, blood LDL cholesterol level, and blood triglyceride levels. Conclusions Our results suggested although the efficacy of three SGAs was similar, there were the differences in the safety profile among the SGAs.
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