Table 1. Results and comparison of clinical trials where lumateperone was used in patients with schizophrenia.

PANSS: Positive and Negative Syndrome Scale; CGI-S: Clinical Global Impression-Severity; EPS: extrapyramidal symptoms.

 

Clinical trial	Number of participants	Length of study	Type of study	Endpoint measurements	Treatment arms	Results
Lieberman et al., 2015 [17]	335	Four weeks	Randomized, double-blind, placebo-controlled, and active-controlled	PANSS score	Lumateperone (42 mg and 84 mg), risperidone, placebo	-Lumateperone 42 mg showed greater antipsychotic efficacy compared to placebo, reducing positive symptoms significantly.   -Lumateperone 84 mg reduced positive symptoms and general psychopathology but did not reach statistical significance compared to placebo.   -Both doses of lumateperone were well tolerated with low discontinuation rates and adverse events.   -Somnolence/sedation was the most commonly reported adverse event, with higher incidence rates for lumateperone 84 mg.   -Neither dose of lumateperone was associated with EPS.   -Lumateperone had a benign metabolic profile, with lower prolactin levels, fasting glucose, total cholesterol, and triglycerides compared to risperidone.   -There was a tendency for less weight gain with lumateperone compared to risperidone, but the difference did not reach statistical significance.
Corell et al, 2020 [18]	450	Four weeks	Randomized, double-blind, placebo-controlled	PANSS score	Lumateperone 28mg/d, 42mg/d, placebo	-Administration of 42 mg of lumateperone resulted in a significant improvement in the PANSS total score compared to placebo (-4.2; p = 0.02).   -Patients who received 28 mg of lumateperone showed a minor reduction in symptoms (-2.6; p = 0.16) compared to the 42 mg group but did not differ significantly from placebo.