Improvement in prosocial symptom domain scores¹

Study design

• 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 4 weeks 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.²
• 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

Full chart description

This graph depicts the change in prosocial symptom domain over 4 weeks for patients receiving CAPLYTA 42 mg or placebo.

At 4 weeks, patients on CAPLYTA saw a 5.0-point reduction vs 2.5-point reduction for those on placebo.