Efficacy

CAPLYTA showed statistically significant improvement as monotherapy or as adjunctive therapy with lithium or valproate1

Primary efficacy results in Study 1 and Study 2

CAPLYTA 42 mg (n=188)

Placebo (n=188)

CAPLYTA 42 mg (n=188)

Placebo (n=188)

CAPLYTA 42 mg + lithium or valproate (n=174)

Placebo + lithium or valproate (n=174)

CAPLYTA showed a statistically significant improvement in both MADRS total score and the key secondary endpoint (CGI‑BP‑S total score in Study 1 and CGI‑BP‑S depression score in Study 2) at Week 61

CGI-BP-S=Clinical Global Impression-Bipolar-Severity of Illness scale; LSM=least squares mean; MADRS=Montgomery-Asberg Depression Rating Scale.

*Statistically significantly superior to placebo.1

Full chart description

These graphs depict the results of the primary endpoint, which was the change in MADRS total score at Week 6.

In Study 1, CAPLYTA 42 mg showed a 16.7‑point decrease in MADRS total score from baseline vs 12.1‑point decrease with placebo.

In Study 2, CAPLYTA 42 mg + lithium or valproate showed a 16.9‑point decrease in MADRS total score from baseline vs 14.5‑point decrease with placebo + lithium or valproate.

Change in baseline MADRS total score in bipolar depression Study 1

Monotherapy
Change from Baseline in MADRS Total Score by Week1,2

Limitation: The weekly time points prior to week 6 were not powered for statistical analysis and should be considered descriptive only. Therefore, the results require cautious interpretation and could represent chance findings.

*P=nominal.
Statistically significantly superior to placebo.
P<0.0001.1-3

Full chart description

This graph depicts the change in baseline MADRS total score by week, over a 6-week period.

CAPLYTA 42 mg showed a 16.7‑point reduction from baseline compared to 12.1‑point reduction with placebo.

References: 1. CAPLYTA prescribing information, 2021.
2. Calabrese JR, Durgam S, Satlin A, et al. Efficacy and safety of lumateperone for major depressive episodes associated with bipolar I or bipolar II disorder: a phase 3 randomized placebo-controlled trial. Am J Psychiatry. Published online September 23, 2021. doi:10.1176/appi.ajp.2021.20091339
3. Data on File. 2021.