Efficacy

In 2 clinical trials, CAPLYTA demonstrated statistically superior improvement vs placebo in symptoms of schizophrenia1

Study 1. CAPLYTA demonstrated significant improvement in PANSS (Positive and Negative Syndrome Scale) total score at Day 281,2*

This study was not designed to allow for efficacy comparison of CAPLYTA and risperidone. Risperidone was included for assay sensitivity.1,2

CAPLYTA® (lumateperone) demonstrated significant improvement in PANSS (Positive and Negative Syndrome Scale) total score at Day 28

This study was not designed to allow for efficacy comparison of CAPLYTA and risperidone.
Risperidone was included for assay sensitivity.1,2

Study 2. Change from baseline in PANSS total score1,4*

Change from baseline in PANSS total score

Limitation: The weekly time points prior to Day 28 were not powered for statistical comparison and are descriptive only.

CAPLYTA demonstrated significant improvement
in Clinical Global Impression-Severity (CGI-S) score3||

CGI-S was a secondary endpoint3

Patients on CAPLYTA 42 mg saw a 0.8 improvement in CGI-S score vs 0.5 on placebo (P<.05). Baseline CGI-S scores (mean) were 4.8 for CAPLYTA 42 mg and placebo.3

Frequently asked questions about efficacy

References: 1. CAPLYTA full prescribing information. 2. Lieberman JA, Davis RE, Correll CU, et al. CAPLYTA for the treatment of schizophrenia: a 4-week randomized, double-blind, controlled trial. Biol Psychiatry. 2016;79(12):952-961.

LSM=least squares mean.

The PANSS is a 30-item scale used to measure symptoms of schizophrenia. Each item is rated by a clinician on a 7-point scale. A score of 1 indicates the absence of symptoms, and a score of 7 indicates extremely severe symptoms. The PANSS total score may range from 30 to 210, with higher scores reflecting greater overall symptom severity.1

The CGI-S asks the clinician how mentally ill the patient is, which is rated on the following 7-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.5