||A Phase 3, randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ITI-007 adjunctive to lithium or valproate in the treatment of patients with major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
||Intra-Cellular Therapies, Inc. (ITI)
||Approximately 30 study sites in 1 country (United States)
||Major depressive episodes associated with bipolar I or bipolar II disorder (bipolar depression)
||The primary objective of this study is to compare the efficacy of 2 doses of ITI-007 adjunctive to treatment with lithium or valproate, administered orally once daily, to that of placebo adjunctive to treatment with lithium or valproate in absolute mean change from baseline in the total score of the rateradministered Montgomery-Åsberg Depression Rating Scale (MADRS) in patients with bipolar depression at Week 6.