Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of ITI-007 Monotherapy 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)
- 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 expect to file an NDA for bipolar depression in 2H 2019, on the basis of outcome of this and other (CTP 700287707) trial.
- 01 Mar 2018 According to an Intra-Cellular Therapies media release, top-line results are expected in 2H 2018.
- 15 Mar 2017 Planned End Date changed from 1 Dec 2017 to 1 Aug 2018.