FDA Approves Caplyta for Major Depressive Disorder in Adults

THURSDAY, Nov. 13, 2025 (HealthDay News) — The U.S. Food and Drug Administration 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.

Two phase 3 trials (study 501 and 502) informed the approval. The trials 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.

A benefit was seen at six weeks for the total MADRS score, favoring Caplyta versus placebo. Separation from placebo was seen as early as one week in study 501 and two weeks in study 502. For the key secondary end point of mean change in total CGI-S scores, significant reductions from baseline were also seen at six weeks in both studies.

“Depression is a complex disorder that affects each person differently, underscoring the urgent need for a range of effective and well-tolerated treatment options,” Roger S. McIntyre, M.D., from University of Toronto, said in a statement. “For people who are still experiencing lingering depressive symptoms while on an antidepressant, adding Caplyta to a patient”s treatment regimen may offer early improvement, with the potential for remission — the ultimate goal of treatment.”

Approval of Caplyta was granted to Johnson & Johnson.

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