deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02418585

A Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Participants With Treatment-resistant Depression (TRANSFORM-2)

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

Sponsor: Janssen Research & Development, LLC

Conditions Treatment-resistant Depression
Interventions Duloxetine (Oral Antidepressant) Escitalopram (Oral antidepressant) Esketamine Placebo Sertraline (Oral Antidepressant) Venlafaxine Extended Release (XR) (Oral Antidepressant)
Updated 16 times since 2017 Last updated: Apr 25, 2025 Started: Aug 7, 2015 Primary completion: Jun 1, 2017 Completion: Nov 6, 2017
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 16 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 – ~Apr 2017 · 59 days · monthly snapshot~Apr 2017 – ~Jun 2017 · 2 months · monthly snapshot~Jun 2017 – ~Sep 2017 · 3 months · monthly snapshot~Sep 2017 – ~Dec 2017 · 3 months · monthly snapshot~Dec 2017 – ~Jun 2018 · 6 months · monthly snapshot~Jun 2018 – ~May 2019 · 11 months · monthly snapshot~May 2019 – ~Jul 2020 · 14 months · monthly snapshot~Jul 2020 – ~Jan 2021 · 6 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 · 10 months · monthly snapshot

Change History

16 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 11 earlier versions

  1. Dec 2021 — Jul 2024 [monthly]

    Completed PHASE3

  2. Jan 2021 — Dec 2021 [monthly]

    Completed PHASE3

  3. Jul 2020 — Jan 2021 [monthly]

    Completed PHASE3

  4. May 2019 — Jul 2020 [monthly]

    Completed PHASE3

  5. Jun 2018 — May 2019 [monthly]

    Completed PHASE3

  6. Dec 2017 — Jun 2018 [monthly]

    Completed PHASE3

    Status: Active Not Recruiting → Completed

  7. Sep 2017 — Dec 2017 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting

  8. Jun 2017 — Sep 2017 [monthly]

    Recruiting PHASE3

  9. Apr 2017 — Jun 2017 [monthly]

    Recruiting PHASE3

  10. Feb 2017 — Apr 2017 [monthly]

    Recruiting PHASE3

  11. 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

Alcorcón, Spain , Atlanta, United States , Barcelona, Spain , Berlin, Germany , Bialystok, Poland , Birmingham, United States , Boston, United States , Bydgoszcz, Poland , Cham, Germany , Chicago, United States and 38 more locations