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An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

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Trial Profile

An Open-label, Multicenter Trial to Assess the Safety and Tolerability of Lumateperone as Adjunctive Therapy in the Treatment of Patients With Major Depressive Disorder

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 21 May 2026

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At a glance

  • Drugs Lumateperone (Primary)
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms 503
  • Sponsors Intra-Cellular Therapies

Most Recent Events

  • 11 May 2026 According to an Johnson & Johnson media release, the data from the trial will be presented at the American Psychiatric Association (APA 2026) Annual Meeting and the American Society of Clinical Psychopharmacology (ASCP 2026) Annual Meeting.
  • 19 Dec 2024 Status changed from recruiting to completed.
  • 07 Jan 2024 This trial has been Discontinued at Finland, According to European Clinical Trials Database record.

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