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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

Trial Profile

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

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 17 Jan 2019

At a glance

  • Drugs Lumateperone (Primary)
  • Indications Bipolar depression
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies
  • Most Recent Events

    • 03 Jan 2019 Planned End Date changed from 1 May 2019 to 1 Jun 2019.
    • 03 Jan 2019 Planned primary completion date changed from 1 Feb 2019 to 1 Jun 2019.
    • 03 Jan 2019 Status changed from recruiting to active, no longer recruiting.
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