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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: 11 Dec 2025

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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

  • 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.
  • 07 Nov 2024 Results published in the Intra-Cellular Media Release.

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