Is Lumateperone Effective in Bipolar Depression? A Systematic Literature Review and Meta-Analysis on Placebo-Controlled Trials.

Bipolar depression is often difficult to treat and needs a specific therapeutic approach. This systematic review and meta-analysis aimed to evaluate the efficacy of lumateperone to be inclusive of more recently published studies with this agent in depressive episodes of bipolar disorder. Three meta-analyses were conducted to determine whether the mean Montgomery-Asberg Depression Rating Scale (MADRS) values in the placebo groups differ significantly from the mean MADRS scale values in the group receiving lumateperone 42 mg and whether the mean of Clinical Global Impression Bipolar Version - Severity Scale (CGI-BP-S) - (depression subscore and overall bipolar illness) values in the placebo groups differ significantly from the mean CGI-BP-S scale values in the group receiving lumateperone 42 mg. The meta-analysis showed a statistically significant difference between patients treated with lumateperone 42 mg and those treated with placebo for the MADRS and CGI subscores. The clinical profile of lumateperone indicates that it is a established and highly efficacious treatment option for major depressive episodes associated with bipolar disorder.