The study will be conducted in the following 5 phases:~A no-drug Screening Phase up to 7 days in duration during which patient eligibility will be assessed;~A 6-week, open-label Run-in Phase (RIP) during which all patients will receive oral lumateperone 42 mg/day;~A 12-week, open-label Stabilization Phase (SP) during which all patients will receive oral lumateperone 42 mg/day;~A Double-blind Treatment Phase (DBTP) 26 weeks in duration during which patients receive either lumateperone 42 mg or placebo (1:1 ratio);~A 2-week Safety Follow-up (SFU) Phase.
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study in adult patients with a primary diagnosis of schizophrenia according to criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, (DSM-5).