Efficacy

A randomized, double-blind, placebo-controlled, multicenter, inpatient clinical trial that enrolled patients with an acute exacerbation of schizophrenia. The primary endpoint was change from baseline in the PANSS total score at Day 28 compared to placebo. Patients were screened for up to a 7-day drug-free period. All treatments were dosed as oral monotherapy once daily in the morning for 4 weeks.^1,2

Study 1 randomized 335 patients to either CAPLYTA 42 mg, CAPLYTA 84 mg, active comparator, or placebo in a 1:1:1:1 fashion. Patients were generally moderately to markedly ill. Median age was 42 years (range 20 to 55 years). 17% were female, 19% were Caucasian, and 78% were African American. The treatment effect in the CAPLYTA 84 mg group (vs placebo) was not statistically significant.^1,3

The PANSS Prosocial Subscale is a 6-item scale derived from the PANSS Total score to measure social functioning. It includes the following symptoms: hallucinatory behavior, suspiciousness/persecution, emotional withdrawal, passive social withdrawal, stereotyped thinking, and active social avoidance. 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.^1,2

This graph depicts the change in prosocial symptom domain over 28 days for patients receiving CAPLYTA 42 mg or placebo.

At Day 28, patients on CAPLYTA saw a 5.0-point reduction vs 2.5-point reduction for those on placebo.