A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Lumateperone Monotherapy in the Treatment of Patients With Major Depressive Episodes Associated With Bipolar I or Bipolar II Disorder (Bipolar Depression) Conducted Globally
Phase of Trial: Phase III
Latest Information Update: 28 Mar 2018
At a glance
- Drugs Lumateperone (Primary)
- Indications Bipolar depression
- Focus 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 700258884) trial.
- 01 Mar 2018 According to an Intra-Cellular Therapies media release, top-line results are expected in 2019.
- 08 Nov 2017 Status changed from not yet recruiting to recruiting.