deltatrials
Completed PHASE4 INTERVENTIONAL 3-arm NCT04599855

A Study of Esketamine Nasal Spray, Administered as Monotherapy, in Adult Participants With Treatment-resistant Depression

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

Sponsor: Janssen Research & Development, LLC

Conditions Depressive Disorder, Treatment-Resistant
Interventions Esketamine 56 mg Esketamine 84 mg Placebo
Updated 42 times since 2020 Last updated: Apr 24, 2025 Started: Nov 4, 2020 Primary completion: Jan 31, 2024 Completion: Jan 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE4 trial investigates Depressive Disorder, Treatment-Resistant and is currently completed. Janssen Research & Development, LLC leads this study, which shows 42 recorded versions since 2020 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Nov 2020 – ~Dec 2020 · 30 days · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Mar 2021 · 28 days · monthly snapshot~Mar 2021 – ~Apr 2021 · 31 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Jun 2021 · 31 days · monthly snapshot~Jun 2021 – ~Sep 2021 · 3 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Nov 2021 · 31 days · monthly snapshot~Nov 2021 – ~Dec 2021 · 30 days · monthly snapshot~Dec 2021 – ~Jan 2022 · 31 days · monthly snapshot~Jan 2022 – ~Feb 2022 · 31 days · monthly snapshot~Feb 2022 – ~Mar 2022 · 28 days · monthly snapshot~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshot~Apr 2022 – ~May 2022 · 30 days · monthly snapshot~May 2022 – ~Jun 2022 · 31 days · monthly snapshot~Jun 2022 – ~Jul 2022 · 30 days · monthly snapshot~Jul 2022 – ~Sep 2022 · 2 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Jan 2023 · 31 days · monthly snapshot~Jan 2023 – ~Feb 2023 · 31 days · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~Apr 2023 · 31 days · monthly snapshot~Apr 2023 – ~May 2023 · 30 days · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshot~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Jan 2024 · 2 months · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Apr 2024 · 2 months · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jan 2025 · 4 months · monthly snapshot~Jan 2025 – ~Apr 2025 · 3 months · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

42 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE4

  2. May 2025 — Sep 2025 [monthly]

    Completed PHASE4

  3. Apr 2025 — May 2025 [monthly]

    Completed PHASE4

  4. Jan 2025 — Apr 2025 [monthly]

    Completed PHASE4

  5. Sep 2024 — Jan 2025 [monthly]

    Completed PHASE4

▶ Show 37 earlier versions

  1. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE4

  2. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE4

    Status: Active Not Recruiting → Completed

  3. Feb 2024 — Apr 2024 [monthly]

    Active Not Recruiting PHASE4

  4. Jan 2024 — Feb 2024 [monthly]

    Active Not Recruiting PHASE4

    Status: Recruiting → Active Not Recruiting

  5. Nov 2023 — Jan 2024 [monthly]

    Recruiting PHASE4

  6. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE4

  7. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE4

  8. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE4

  9. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE4

  10. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE4

  11. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE4

  12. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE4

  13. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE4

  14. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE4

  15. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE4

  16. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE4

  17. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE4

  18. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE4

  19. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE4

  20. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE4

  21. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE4

  22. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE4

  23. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE4

  24. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE4

  25. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE4

  26. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE4

  27. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE4

  28. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE4

  29. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE4

  30. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE4

  31. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE4

  32. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE4

  33. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE4

  34. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE4

  35. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE4

    Status: Not Yet Recruiting → Recruiting

  36. Dec 2020 — Jan 2021 [monthly]

    Not Yet Recruiting PHASE4

  37. Nov 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE4

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Janssen Research & Development, LLC
Data source: Janssen Research & Development, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Allentown, United States , Ann Arbor, United States , Atlanta, United States , Austin, United States , Baltimore, United States , Birmingham, United States , Boston, United States , Charlottesville, United States , Chicago, United States , Columbus, United States and 37 more locations