deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02422186

A Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression (TRANSFORM-3)

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

Sponsor: Janssen Research & Development, LLC

Conditions Depressive Disorder, Treatment-Resistant
Interventions Duloxetine (Oral Antidepressant) Escitalopram (Oral Antidepressant) Esketamine Placebo Sertraline (Oral Antidepressant) Venlafaxine Extended Release (XR) (New Antidepressant)
Updated 20 times since 2017 Last updated: Apr 25, 2025 Started: Aug 20, 2015 Primary completion: Aug 10, 2017 Completion: Aug 10, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Depressive Disorder, Treatment-Resistant, this trial is completed. The trial is conducted by Janssen Research & Development, LLC and has accumulated 20 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshot~Feb 2017 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~May 2017 · 30 days · monthly snapshot~May 2017 – ~Jun 2017 · 31 days · monthly snapshot~Jun 2017 – ~Jul 2017 · 30 days · monthly snapshot~Jul 2017 – ~Aug 2017 · 31 days · monthly snapshot~Aug 2017 – ~Oct 2017 · 2 months · monthly snapshot~Oct 2017 – ~Feb 2018 · 4 months · monthly snapshot~Feb 2018 – ~Jun 2018 · 4 months · monthly snapshot~Jun 2018 – ~Aug 2018 · 2 months · monthly snapshot~Aug 2018 – ~May 2019 · 9 months · monthly snapshot~May 2019 – ~Jul 2020 · 14 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 months · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Jul 2024 · 33 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 · 10 months · monthly snapshot

Change History

20 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 15 earlier versions

  1. Oct 2021 — Jul 2024 [monthly]

    Completed PHASE3

  2. Jan 2021 — Oct 2021 [monthly]

    Completed PHASE3

  3. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

  4. May 2019 — Jul 2020 [monthly]

    Completed PHASE3

  5. Aug 2018 — May 2019 [monthly]

    Completed PHASE3

  6. Jun 2018 — Aug 2018 [monthly]

    Completed PHASE3

  7. Feb 2018 — Jun 2018 [monthly]

    Completed PHASE3

  8. Oct 2017 — Feb 2018 [monthly]

    Completed PHASE3

    Status: Recruiting → Completed

  9. Aug 2017 — Oct 2017 [monthly]

    Recruiting PHASE3

  10. Jul 2017 — Aug 2017 [monthly]

    Recruiting PHASE3

  11. Jun 2017 — Jul 2017 [monthly]

    Recruiting PHASE3

  12. May 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  13. Apr 2017 — May 2017 [monthly]

    Recruiting PHASE3

  14. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  15. 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 .

Study Locations

Aalst, Belgium , Allentown, United States , Badajoz, Spain , Baltimore, United States , Belo Horizonte, Brazil , Bełchatów, Poland , Bilbao, Spain , Bruges, Belgium , Brussels, Belgium , Burgas, Bulgaria and 59 more locations