Intra-Cellular Therapies Announces Positive Phase 3 Topline Results from Study 501 Evaluating Lumateperone as Adjunctive Therapy in Patients with Major Depressive Disorder

Lumateperone 42 mg achieved statistically significant and clinically meaningful results in both the primary and the key secondary endpoints Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.9 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)= 0.61) Lumateperone 42 mg also met the key secondary endpoint of change from baseline at Week 6 on the Clinical Global Impression Scale for ...