deltatrials
Completed PHASE2 INTERVENTIONAL 6-arm NCT04521478

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants.

Sponsor: Boehringer Ingelheim

Conditions Depressive Disorder, Major
Interventions BI 1358894 Placebo Quetiapine
Updated 44 times since 2020 Last updated: Feb 17, 2025 Started: Nov 20, 2020 Primary completion: Jan 10, 2024 Completion: Feb 2, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE2 clinical study on Depressive Disorder, Major, this trial is completed. The trial is conducted by Boehringer Ingelheim and has accumulated 44 data snapshots since 2020. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Nov 2020 · 31 days · 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 – ~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 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~Jul 2024 · 3 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Apr 2025 · 7 months · monthly snapshot~Apr 2025 – ~Sep 2025 · 5 months · monthly snapshot~Sep 2025 – present · 9 months · monthly snapshot

Change History

44 versions recorded

  1. Sep 2025 — Present [monthly]

    Completed PHASE2

  2. Apr 2025 — Sep 2025 [monthly]

    Completed PHASE2

  3. Sep 2024 — Apr 2025 [monthly]

    Completed PHASE2

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  5. Apr 2024 — Jul 2024 [monthly]

    Completed PHASE2

▶ Show 39 earlier versions

  1. Mar 2024 — Apr 2024 [monthly]

    Completed PHASE2

    Status: Active Not Recruiting → Completed

  2. Feb 2024 — Mar 2024 [monthly]

    Active Not Recruiting PHASE2

  3. Jan 2024 — Feb 2024 [monthly]

    Active Not Recruiting PHASE2

  4. Dec 2023 — Jan 2024 [monthly]

    Active Not Recruiting PHASE2

    Status: Recruiting → Active Not Recruiting

  5. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE2

  6. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE2

  7. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE2

  8. Aug 2023 — Sep 2023 [monthly]

    Recruiting PHASE2

  9. Jul 2023 — Aug 2023 [monthly]

    Recruiting PHASE2

  10. Jun 2023 — Jul 2023 [monthly]

    Recruiting PHASE2

  11. May 2023 — Jun 2023 [monthly]

    Recruiting PHASE2

  12. Apr 2023 — May 2023 [monthly]

    Recruiting PHASE2

  13. Mar 2023 — Apr 2023 [monthly]

    Recruiting PHASE2

  14. Feb 2023 — Mar 2023 [monthly]

    Recruiting PHASE2

  15. Jan 2023 — Feb 2023 [monthly]

    Recruiting PHASE2

  16. Dec 2022 — Jan 2023 [monthly]

    Recruiting PHASE2

  17. Nov 2022 — Dec 2022 [monthly]

    Recruiting PHASE2

  18. Sep 2022 — Nov 2022 [monthly]

    Recruiting PHASE2

  19. Jul 2022 — Sep 2022 [monthly]

    Recruiting PHASE2

  20. Jun 2022 — Jul 2022 [monthly]

    Recruiting PHASE2

  21. May 2022 — Jun 2022 [monthly]

    Recruiting PHASE2

  22. Apr 2022 — May 2022 [monthly]

    Recruiting PHASE2

  23. Mar 2022 — Apr 2022 [monthly]

    Recruiting PHASE2

  24. Feb 2022 — Mar 2022 [monthly]

    Recruiting PHASE2

  25. Jan 2022 — Feb 2022 [monthly]

    Recruiting PHASE2

  26. Dec 2021 — Jan 2022 [monthly]

    Recruiting PHASE2

  27. Nov 2021 — Dec 2021 [monthly]

    Recruiting PHASE2

  28. Oct 2021 — Nov 2021 [monthly]

    Recruiting PHASE2

  29. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE2

  30. Jun 2021 — Sep 2021 [monthly]

    Recruiting PHASE2

  31. May 2021 — Jun 2021 [monthly]

    Recruiting PHASE2

  32. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2

  33. Mar 2021 — Apr 2021 [monthly]

    Recruiting PHASE2

  34. Feb 2021 — Mar 2021 [monthly]

    Recruiting PHASE2

  35. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2

  36. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2

    Status: Not Yet Recruiting → Recruiting

  37. Nov 2020 — Dec 2020 [monthly]

    Not Yet Recruiting PHASE2

  38. Oct 2020 — Nov 2020 [monthly]

    Not Yet Recruiting PHASE2

  39. Sep 2020 — Oct 2020 [monthly]

    Not Yet Recruiting PHASE2

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Boehringer Ingelheim
Data source: Boehringer Ingelheim

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

Study Locations

Alcorcón, Spain , Allentown, United States , Atlanta, United States , Bad Homburg, Germany , Banská Bystrica, Slovakia , Barcelona, Spain , Birmingham, United States , Bratislava, Slovakia , Budapest, Hungary , Burgas, Bulgaria and 89 more locations