drugset / Trial / NCT02600507
Clinical Trial Evaluating ITI-007 as an Adjunctive Therapy to Lithium or Valproate for the Treatment of Bipolar Depression
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
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 |