deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT04513912

A Study of Seltorexant Compared to Quetiapine XR as Adjunctive Therapy to Antidepressants in Adult and Elderly Participants With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Double-Blind, Randomized, Parallel-Group Study With Quetiapine Extended Release as Comparator to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients With Major Depressive Disorder With Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy

Sponsor: Janssen Research & Development, LLC

Updated 41 times since 2020 Last updated: Aug 11, 2025 Started: Sep 15, 2020 Primary completion: Oct 3, 2023 Completion: Oct 3, 2023
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, Major, this trial is completed. The trial is conducted by Janssen Research & Development, LLC and has accumulated 41 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Sep 2020 – ~Nov 2020 · 2 months · monthly snapshot~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 – ~Apr 2023 · 59 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 – ~Jan 2024 · 3 months · monthly snapshot~Jan 2024 – ~Jul 2024 · 6 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Jan 2025 · 2 months · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · 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

41 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. Feb 2025 — Mar 2025 [monthly]

    Completed PHASE3

  5. Jan 2025 — Feb 2025 [monthly]

    Completed PHASE3

Show 36 earlier versions
  1. Nov 2024 — Jan 2025 [monthly]

    Completed PHASE3

  2. Sep 2024 — Nov 2024 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2024 — Jul 2024 [monthly]

    Completed PHASE3

    Status: RecruitingCompleted

  5. Oct 2023 — Jan 2024 [monthly]

    Recruiting PHASE3

  6. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE3

  7. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE3

  8. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE3

  9. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE3

  10. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE3

  11. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE3

  12. Feb 2023 — Apr 2023 [monthly]

    Recruiting PHASE3

  13. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE3

  14. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE3

  15. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE3

  16. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE3

  17. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE3

  18. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE3

  19. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE3

  20. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE3

  21. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE3

  22. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE3

  23. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE3

  24. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE3

  25. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE3

  26. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE3

  27. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE3

  28. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE3

  29. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE3

  30. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE3

  31. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE3

  32. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE3

  33. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE3

  34. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE3

  35. Nov 2020 — Dec 2020 [monthly]

    Recruiting PHASE3

    Status: Not Yet RecruitingRecruiting

  36. Sep 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE3

    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 .