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

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 (4.5 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)=0.56) Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology SelfReport (QIDS-SR) scale, a patient self-reported measure of symptom severity of depression (p<0.0001) Supplemental NDA (sNDA) submission for the adjunctive treatment of m ...