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An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

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Trial Profile

An Open-label, Long-term, Safety and Efficacy Study of Intranasal Esketamine in Treatment-resistant Depression

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Feb 2025

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At a glance

  • Drugs Esketamine (Primary) ; Duloxetine; Escitalopram; Sertraline; Venlafaxine
  • Indications Major depressive disorder
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms SUSTAIN-2
  • Sponsors Janssen Research & Development; Janssen-Cilag

    • Most Recent Events

    • 16 Dec 2022 Results of post hoc analysis (n=764) assessing long term safety, relationships between dissociation and psychotic symptoms assessed by clinician report versus conventional rating scales, published in the International Journal of Neuropsychopharmacology.
    • 09 Nov 2022 Results from ICEBERG study - which is performed using data from SUSTAIN-2 and other study, estimating the benefit of Esketamine Nasal Spray Versus real-world treatment on patient reported functional Remission, presented at the 25th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 19 Sep 2022 Results of post hoc and pooled analysis from NCT02493868 and NCT02497287 describing the tolerability of esketamine nasal spray based on the adverse event profile observed during treatment sessions occurring early and later over the course of treatment, published in the Journal of Clinical Psychiatry

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