Intra-Cellular Reports Phase 3 Clinical Development Program In Bipolar Disorder

(RTTNews) - Intra-Cellular Therapies, Inc. (ITCI) Wednesday said that, following communication with the FDA, it is proceeding with Phase 3 development of ITI-007 for the treatment of depressive episodes associated with bipolar disorder.

The Phase 3 program in bipolar depression consists of two multicenter, randomized, double-blind, placebo-controlled clinical trials.

The first Phase 3 study will evaluate ITI-007 as a monotherapy and the second Phase 3 study will evaluate ITI-007 as an adjunctive therapy with lithium or valproate. The company plans to commence these studies later this year.