Improvement in PANSS
symptom domains¹

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

Full chart description

This graph depicts the change from baseline in positive, negative, and general psychopathology subscale symptoms of schizophrenia over 4 weeks for patients receiving CAPLYTA 42 mg or placebo.

Baseline PANSS total scores were 88.1 for CAPLYTA and 86.3 for placebo. At 4 weeks, patients on CAPLYTA saw a 4.7-point reduction in positive symptoms vs 2.3-point reduction for those on placebo. Patients on CAPLYTA saw a 1.2-point reduction in negative symptoms vs 0.3-point reduction for those on placebo. Patients on CAPLYTA saw a 6.3-point reduction in GPS symptoms vs 3.6-point reduction for those on placebo.