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.
Phase of Trial: Phase III
Latest Information Update: 01 Mar 2018
At a glance
- Drugs Lumateperone (Primary) ; Lithium; Valproate
- Indications Bipolar depression; Bipolar I disorders; Bipolar II disorders
- Focus Registrational; Therapeutic Use
- Sponsors Intra-Cellular Therapies
- 01 Mar 2018 According to an Intra-Cellular Therapies media release, company is expanding this study clinical sites outside the United States and expect to provide our anticipated timelines for this study after completing the expansion.
- 15 Mar 2017 Planned End Date changed from 1 Dec 2017 to 1 Feb 2019.
- 15 Mar 2017 Planned primary completion date changed from 1 Oct 2017 to 1 Feb 2019.