Key clinical point: Lumateperone demonstrates efficacy with favorable safety and tolerability for the treatment of schizophrenia.

Major finding: Lumateperone 42 mg showed significant improvement from baseline to day 28 on the Positive and Negative Syndrome Scale total score (effect size, −0.3; P = .02) and the Clinical Global Impression-Severity of Illness score (effect size, −0.4; P = .003) vs. placebo. Lumateperone was well tolerated without any serious and unexpected drug reactions.

Study details: A randomized, double-blind, phase 3 clinical trial evaluated the efficacy and safety of lumateperone vs. placebo for the short-term (4 weeks) treatment of schizophrenia.

Disclosures: The study was supported by Intra-Cellular Therapies Inc. Some of the authors reported receiving personal fees from Intra-Cellular or being a consultant for Intra-Cellular.