Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression

Phase 3 Completed 529 enrolled Intra-Cellular Therapies, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The study will evaluate the efficacy and safety of ITI-007 adjunctive to lithium or valproate in a randomized, double-blind, parallel-group, placebo-controlled, multi-center study in patients diagnosed with Bipolar I or Bipolar II disorder having a major depressive episode.

Timeline

Start: 2016-03-07
Primary completion: 2020-07-02
Completion: 2020-07-02

Outcome

Met primary endpoint

registry Lumateperone 42 mg (ITI-007 60 mg Tosylate) vs Placebo; p = 0.021; Least Squares Mean Difference -2.4 NCT02600507 ↗

Publications

Durgam S, Lakkis H, Kozauer SG, Chen C, McIntyre RS. Efficacy of Lumateperone in depression associated with bipolar II disorder: a pooled analysis of late-phase clinical trials. CNS Spectr. 2025 Sep 29;30(1):e80. doi: 10.1017/S1092852925100564.
Suppes T, Durgam S, Kozauer SG, Chen R, Lakkis HD, Davis RE, Satlin A, Vanover KE, Mates S, McIntyre RS, Tohen M. Adjunctive lumateperone (ITI-007) in the treatment of bipolar depression: Results from a randomized placebo-controlled clinical trial. Bipolar Disord. 2023 Sep;25(6):478-488. doi: 10.1111/bdi.13310. Epub 2023 Feb 26.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lumateperone	Small molecule	28 mg	Oral
Subject	Lumateperone	Small molecule	42 mg	Oral