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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: 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 Registrational; Therapeutic Use
  • Acronyms study 501
  • 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.
  • 06 Nov 2025 According to an Intra-Cellular Therapies media release, based on Study 501 and Study 502, the U.S. Food and Drug Administration (FDA) approved CAPLYTA (lumateperone) as an adjunctive therapy with antidepressants for the treatment of major depressive disorder (MDD) in adults.
  • 03 Dec 2024 According to an Intra-Cellular Therapies media release, the company announced that it has recently submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for CAPLYTA (lumateperone) for the treatment of Major Depressive Disorder (MDD) in adults, as adjunctive therapy to antidepressants. The submission is on the basis of Study 501 and Study 502.

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