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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 2024

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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

    • 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.
    • 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.

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