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.

Trial Profile

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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Aug 2017

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
  • Most Recent Events

    • 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.
    • 01 Mar 2017 According to an Intra-Cellular Therapies media release, enrollment is expected to be completed in the second half of 2018.
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