Efficacy and safety of lurasidone versus placebo as adjunctive to mood stabilizers in bipolar I depression: A meta-analysis.

BACKGROUND

Few evidence-based treatments and guidelines reflect greater uncertainty regarding consensus treatment algorithms than those for unipolar disorder. This meta-analysis aimed to evaluate the efficacy and side effects of lurasidone by comparing with placebo in bipolar I depression.

METHODS

Electronic databases, such as PubMed, the Cochrane Library, Web of Science, and Embase, were searched until May 30, 2018, for randomized controlled trials on comparison lurasidone therapy with placebo. The primary efficacy assessment included MADRS total score and CGI-BP-S total score, the secondary efficacy assessment included the response and the remission rates and the safety and tolerability were also evaluated applying the Simpson-Angus Scale.

RESULTS

The meta-analysis compromised 7 studies. Efficacy analysis suggested that lurasidone was more effective than placebo: MADRS total score (MD:-4.31, 95%CI: (-6.93,-1.7), P = 0.001) and the CGI-BP-S total score (MD:-0.37, 95%CI: (-0.59,-0.15), P = 0.0008) were obtained for both lurasidone-treated and placebo groups. Response rates (RR: 1.73, 95%CI: (1.46, 2.05), P < 0.00001) and Remission rates (RR: 1.57, 95%CI: (1.38, 1.79), P < 0.00001). The safety analysis between lurasidone and placebo showed no difference: at least one event (RR: 1.12, 95% CI :(1.00, 1.26), p = 0.05 and the influence on glucose (MD: 0.35, 95% CI :(-1.09, 1.79), p = 0.63.

LIMITATION

The present conclusion is limited by the limited included studies. The different dose of lurasidone should be considered in the future.

CONCLUSION

Compared with placebo, adjunctive lurasidone significantly improved depressive symptoms and is very well tolerated with minimal side effects on the endocrine and cardiovascular systems in clinical patients with bipolar I depression. Key words: Bipolar I depression; Lurasidone; Meta-analysis; Remission rates; Adverse effect.