Intra-Cellular Therapies: Positive Topline Results from Depression Study

 Lumateperone 42mg was statistically significant on the primary endpoint of symptom reduction on the Montgomery Asberg Depression Rating Scale (MADRS) for each patient population including:

-combined major depressive disorder (MDD) with mixed features and bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; Cohen’s d effect size (ES) = 0.64)
-MDD with mixed features (5.9 point reduction v. placebo; p<0.0001; ES= 0.67)
-bipolar depression with mixed features (5.7 point reduction v. placebo; p<0.0001; ES= 0.64)

Lumateperone 42mg was statistically significant on the key secondary endpoint of the clinician’s assessment of improvement in the overall severity on the Global Impression of Severity Scale (CGI-S) for each patient population including:

-combined MDD with mixed features and bipolar depression with mixed features (p<0.0001; ES= 0.59)
-MDD with mixed features (p=0.0003; ES= 0.57)
-bipolar depression with mixed features (p<0.0001; ES= 0.61)

Favorable safety and tolerability profile observed, consistent with prior lumateperone trials

Conference call scheduled today at 8:30 a.m. ET

The Company will host a live conference call and webcast today at 8:30 AM Eastern Time to discuss the results of Study 403. To attend the live conference call by phone please use this registration link. All participants must use the link to complete the online registration process in advance of the conference call.

The live and archived webcast can be accessed under "Events & Presentations" in the Investors section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software.

CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate.

https://finance.yahoo.com/news/intra-cellular-therapies-announces-positive-110000681.html