There is currently no cure for schizophrenia, but the condition can be treated and managed. Lumateperone is an antipsychotic medication considered to be a potential treatment for schizophrenia. This study aims to evaluate the safety and efficacy of lumateperone in the treatment of schizophrenia.
This is a randomized, placebo-controlled, double-blind, phase-3 clinical trial that included a total of 450 patients with schizophrenia aged 18-60 years who were experiencing an acute exacerbation of psychosis. The participants were randomly assigned in a 1:1:1 ratio (150 patients each) to receive 60 mg lumateperone tosylate, 40 mg lumateperone tosylate, and placebo once daily for 4 weeks. The primary outcome of the study was the primary efficacy and safety of lumateperone measured by PANSS subscale scores, CGI-S score, social function, safety, and tolerability.
The findings suggested that 40 mg lumateperone met the primary and key secondary efficacy objective, showing a significant improvement in PANSS total score when compared with the placebo. The 60 mg lumateperone dose was also well-tolerated without any clinically significant treatment-related adverse events.
The research concluded that lumateperone showed statistically significant improvements in improvement in the symptoms of schizophrenia, with a favorable safety profile. Therefore, lumateperone can be used as a potential treatment for schizophrenia.