SUMMARY

• An open-label, long-term study evaluated the effectiveness and safety of CAPLYTA 42 mg in patients with schizophrenia and stable symptoms (N=602).^1,2
  • An interim analysis of 107 patients noted a reduction in the mean Calgary Depression Scale for Schizophrenia (CDSS) score from 7.4 at baseline to 3.1 on day 300 in patients with moderate to severe depressive symptoms at baseline.¹
  • A later analysis with 239 patients reported that in the overall population, there was a significant decrease in the mean CDSS score from baseline (2.2) to day 368 (mean change from baseline: -0.6; 95% confidence interval [CI]: -1.1 to -0.1; P=0.01).²
• A randomized, double-blind, placebo- and active-controlled, multicenter, phase 2 clinical trial evaluated the efficacy and safety of CAPLYTA in patients with schizophrenia (N=335).³
  • The mean (standard error of the mean [SEM]) change from baseline to day 28 in the CDSS score in the CAPLYTA 84 mg, CAPLYTA 42 mg, risperidone 4 mg, and placebo arms was -5.6 (0.74), -7.7 (0.42), -7.2 (1.31), and -5.4 (1.00), respectively.
• A phase 3, randomized, double-blind, placebo-controlled, multicenter study evaluated the efficacy and safety of CAPLYTA in patients with schizophrenia (N=450).^4,5
  • The mean (standard deviation [SD]) change from baseline to day 28 in the CDSS score in the CAPLYTA 42 mg, CAPLYTA 28 mg, and placebo arms was 9.8 (2.64), 8.9 (1.88), and 9.0 (1.99), respectively. The changes were not statistically significant.⁴
• Data were derived from small sample sizes as the clinical studies were not powered to measure depressive symptoms. Therefore, the results require cautious interpretation and could represent chance findings.

CLINICAL DATA

Correll et al (2020)¹ and Satlin et al (2019)² presented the results of an open-label, long-term study that evaluated the effectiveness and safety of CAPLYTA 42 mg in patients with schizophrenia and stable symptoms (N=602).

• Patients with stable schizophrenia were switched from standard-of-care antipsychotics to CAPLYTA 42 mg for up to 1 year.
• At the time of the interim analysis, of the 602 patients who had received at least 1 dose of CAPLYTA, 107 patients had completed 1 year of treatment.¹
  • The mean CDSS score in patients with moderate to severe depressive symptoms at baseline (CDSS score >5) decreased from 7.4 at baseline to 3.1 on day 300.
  • By day 75, 60% of patients met CDSS response criteria, defined as 50% improvement from baseline in the CDSS score; this response rate was maintained through day 300.
• A later analysis was performed after 239 patients had completed 1 year of treatment.²
  • The mean CDSS score in the overall population was 2.2 at baseline and decreased significantly on day 368 (mean change from baseline: -0.6; 95% CI: -1.1 to -0.1; P=0.01).
  • Larger improvements were observed in patients with moderate to severe depressive symptoms at baseline, with the mean CDSS score improving from 7.9 at baseline to 2.0 on day 368 (P<0.001).

Lieberman et al (2016)³ conducted a randomized, double-blind, placebo- and active-controlled, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of CAPLYTA in patients with schizophrenia (N=335).

• Patients were randomized 1:1:1:1 to receive CAPLYTA 84 mg, CAPLYTA 42 mg, risperidone 4 mg, or placebo for 4 weeks.
• Changes in the CDSS score in the subgroup of patients with depressive symptoms at baseline (CDSS score >6) are summarized in Table: Changes in CDSS Score in Patients with Depressive Symptoms at Baseline.

Correll et al (2020)^4,5 conducted a phase 3, randomized, double-blind, placebo-controlled, multicenter study to evaluate the efficacy and safety of CAPLYTA in patients with schizophrenia.

• Patients were randomized (1:1:1; N=450) to receive CAPLYTA 28 mg (n=150), CAPLYTA 42 mg (n=150), or placebo (n=150) for 4 weeks; this was followed by an approximately 2-week safety follow-up period.
• Overall, 74 patients had a baseline CDSS score of >6.⁴
• The mean (SD) change from baseline to day 28 in the CDSS score in patients with a baseline score of >6 was 9.8 (2.64), 8.9 (1.88), and 9.0 (1.99) in the CAPLYTA 42 mg (n=26), CAPLYTA 28 mg (n=22), and placebo (n=26) arms, respectively. The changes were not statistically significant.
• Patients with a baseline score of >6 in the CAPLYTA 42 mg (n=26) and placebo (n=26) arms had an average change from baseline to day 28 in the CDSS score of -18.8 and
  -10.7, respectively.

Literature Search

A literature search of MEDLINE^®, EMBASE^®, BIOSIS Previews^®, and DERWENT^® (and/or other resources, including internal/external databases) was conducted on 15 September 2025.