In this article, we’ll discuss the basis for the FDA’s approval (in 2025) of lumateperone for “adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults“ (Prescribing Information).
Why? Isn’t it enough for us to know that this is what the FDA approval was for? Some key details of the studies that formed the basis of the FDA approval can help us understand to whom we may consider applying the results of the studies.
The FDA’s approval of lumateperone for “adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults” was based on two large randomized, double-blind, placebo-controlled clinical trials that were submitted to the FDA and have also been published (Durgam et al., 2025a; Durgam et al., 2025b). The studies were conducted by the manufacturer of lumateperone, Intra-Cellular Therapies, which is now owned by Johnson & Johnson.
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