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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) or Major Depressive Disorder

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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) or Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 Mar 2025

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Bipolar depression; Bipolar I disorders; Bipolar II disorders; Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 07 Nov 2024 According to an Intra-Cellular Therapies media release, result from this trial was presented at Psych Congress held October 29- November 2 in Boston and Neuroscience Education Institute (NEI) Congress being held November 7-10 in Colorado Springs.
  • 23 May 2024 According to a Intra-Cellular Therapies media release, data from this study will be presented at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held in Miami, May 28-31, 2024.
  • 22 Feb 2024 According to a Intra-Cellular Therapies media release, results from this trial were presented at the European College of Neuropsychopharmacology Congress.

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