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A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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Trial Profile

A Randomized, Double-Blind, Placebo-controlled Multicenter Study to Assess the Efficacy and Safety of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2025

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Major depressive disorder
  • Focus Registrational; Therapeutic Use
  • Acronyms Study 505
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 01 Nov 2024 Planned End Date changed from 1 Oct 2025 to 1 Oct 2026.
  • 01 Nov 2024 Planned primary completion date changed from 1 Oct 2025 to 1 Sep 2026.
  • 10 May 2023 New trial record

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