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A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

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Trial Profile

A Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 23 Jul 2024

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At a glance

  • Drugs Esketamine (Primary)
  • Indications Major depressive disorder
  • Focus Therapeutic Use
  • Sponsors Janssen Research & Development

    • Most Recent Events

    • 22 Jul 2024 According to a Johnson & Johnson media release, the company announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of SPRAVATO (esketamine) CIII nasal spray as a monotherapy for adults living with treatment-resistant depression (TRD).
    • 17 Jul 2024 According to a Johnson & Johnson media release, additional data from this study presented at the s American Society of Clinical Psychopharmacology (ASCP) Annual Meeting, which is being held from May 28-31 in Miami, Florida.
    • 11 Mar 2024 Status changed from active, no longer recruiting to completed.

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