Additional Relevant Details Study 404 met its primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (p<0.001; effect size = 0.56).
Study 404 also met its key secondary objective on the Clinical Global Impression Scale for Bipolar for Severity of Illness (CGI-BP-S) Total Score (p<0.001; effect size = 0.46); lumateperone also positive on the CGI component that specifically assesses depression (CGI-BP-S Depression Score; p<0.001; effect size = 0.50).Study 404 benefits were statistically significant in both Bipolar I and Bipolar II patients.In Study 401, lumateperone did not separate from placebo. A high placebo response was observed in the trial.Favorable safety and tolerability profile observed in both trials, consistent with prior lumateperone trials. Rates of akathisia, restlessness and extrapyramidal symptoms combined were less than 1% and similar to placebo in both studies.