deltatrials
Completed PHASE3 INTERVENTIONAL 3-arm NCT02417064

A Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-1)

A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression

Sponsor: Janssen Research & Development, LLC

Updated 23 times since 2017 Last updated: Apr 25, 2025 Started: Aug 10, 2015 Primary completion: Feb 20, 2018 Completion: Feb 20, 2018
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE3 trial investigates Treatment-resistant Depression and is currently completed. Janssen Research & Development, LLC leads this study, which shows 23 recorded versions since 2015 — indicating substantial longitudinal coverage. This study adds to the longitudinal dataset for psychiatric treatment development.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Mar 2017 · 28 days · monthly snapshot~Mar 2017 – ~May 2017 · 2 months · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Aug 2017 · 2 months · monthly snapshot~Aug 2017 – ~Sep 2017 · 31 days · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Mar 2018 · 3 months · monthly snapshot~Mar 2018 – ~May 2018 · 2 months · monthly snapshot~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Oct 2018 · 4 months · monthly snapshot~Oct 2018 – ~Nov 2018 · 31 days · monthly snapshot~Nov 2018 – ~Mar 2019 · 4 months · monthly snapshot~Mar 2019 – ~May 2019 · 2 months · monthly snapshot~May 2019 – ~Jun 2020 · 13 months · monthly snapshot~Jun 2020 – ~Jan 2021 · 7 months · monthly snapshot~Jan 2021 – ~Dec 2021 · 11 months · monthly snapshot~Dec 2021 – ~Jul 2024 · 31 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Mar 2025 · 6 months · monthly snapshot~Mar 2025 – ~May 2025 · 2 months · monthly snapshot~May 2025 – ~Sep 2025 · 4 months · monthly snapshot~Sep 2025 – present · 12 months · monthly snapshot

Change History

23 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. May 2025 — Sep 2025 [monthly]

    Completed PHASE3

  3. Mar 2025 — May 2025 [monthly]

    Completed PHASE3

  4. Sep 2024 — Mar 2025 [monthly]

    Completed PHASE3

  5. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

Show 18 earlier versions
  1. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  2. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  3. Jun 2020 — Jan 2021 [monthly]

    Completed PHASE3

  4. May 2019 — Jun 2020 [monthly]

    Completed PHASE3

  5. Mar 2019 — May 2019 [monthly]

    Completed PHASE3

  6. Nov 2018 — Mar 2019 [monthly]

    Completed PHASE3

  7. Oct 2018 — Nov 2018 [monthly]

    Completed PHASE3

  8. Jun 2018 — Oct 2018 [monthly]

    Completed PHASE3

  9. May 2018 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  10. Mar 2018 — May 2018 [monthly]

    Active Not Recruiting PHASE3

  11. Dec 2017 — Mar 2018 [monthly]

    Active Not Recruiting PHASE3

    Status: RecruitingActive Not Recruiting

  12. Sep 2017 — Dec 2017 [monthly]

    Recruiting PHASE3

  13. Aug 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  14. Jun 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  15. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  16. Mar 2017 — May 2017 [monthly]

    Recruiting PHASE3

  17. Feb 2017 — Mar 2017 [monthly]

    Recruiting PHASE3

  18. Jan 2017 — Feb 2017 [monthly]

    Recruiting PHASE3

    First recorded

Aug 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

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 .