HealthDay (11/13, Solomon) reports the FDA has “approved Caplyta (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder in adults. This approval marks the fourth indication for Caplyta, the first and only FDA-approved treatment for bipolar I and II depression in adults, as an adjunctive and monotherapy. Caplyta is also approved for the treatment of schizophrenia in adults.” The approval was based on two phase 3 trials that “showed that Caplyta was associated with statistically significant and clinically meaningful improvement in depression symptoms versus an oral antidepressant plus placebo, as measured by the Montgomery-Asberg Depression Rating Scale (MADRS) and Clinical Global Impression Scale-Severity index (CGI-S) total scores.” (SOURCE: APA Headlines)