Tuesday, Intra-Cellular Therapies Inc ( ITCI ) released topline results from Study 502 evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for the treatment of major depressive disorder (MDD). 

The company expects to submit a supplemental FDA application in the second half of 2024.

Lumateperone 42 mg, given once daily as adjunctive therapy to antidepressants, met the primary endpoint in Study 502 by demonstrating a statistically significant and clinically meaningful reduction in the Montgomery and Asberg Depression Rating Scale (MADRS) total score compared to placebo at Week 6.

MADRS evaluates depression severity.

Related: Intra-Cellular Stock Rallies On Successful Late-Stage Depression Treatment Study.

In the modified intent-to-treat (mITT) study population, the least squares (LS) mean reduction from baseline for lumateperone 42 mg was 14.7 points, versus 10.2 points for placebo (LS mean difference = -4.5 points; p