deltatrials
Unknown PHASE3 INTERVENTIONAL 2-arm NCT03396068

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Suicidal Ideation (SBD-ASIB)

NRX-101 for Maintenance of Remission From Severe Bipolar Depression in Patients With Acute Suicidal Ideation and Behavior: The SBD-ASIB Study

Sponsor: NeuroRx, Inc.

Conditions Bipolar Depression Suicidal Ideation
Interventions Lurasidone HCl NRX-101
Updated 17 times since 2018 Last updated: Jan 17, 2024 Started: Dec 1, 2019 Primary completion: Dec 31, 2024 Completion: Dec 31, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03396068, this PHASE3 trial focuses on Bipolar Depression and Suicidal Ideation and remains ongoing. Sponsored by NeuroRx, Inc., it has been updated 17 times since 2019, reflecting substantial change activity. Mental health research at this phase helps define safety and dosing parameters for future study.

Status Flow

~Jan 2018 – ~Apr 2018 · 3 months · monthly snapshot~Apr 2018 – ~Jun 2018 · 2 months · monthly snapshot~Jun 2018 – ~Dec 2018 · 6 months · monthly snapshot~Dec 2018 – ~Jan 2019 · 31 days · monthly snapshot~Jan 2019 – ~Jul 2019 · 6 months · monthly snapshot~Jul 2019 – ~Aug 2019 · 31 days · monthly snapshot~Aug 2019 – ~Jan 2020 · 5 months · monthly snapshot~Jan 2020 – ~Dec 2020 · 11 months · monthly snapshot~Dec 2020 – ~Jan 2021 · 31 days · monthly snapshot~Jan 2021 – ~Oct 2021 · 9 months · monthly snapshot~Oct 2021 – ~Sep 2022 · 11 months · monthly snapshot~Sep 2022 – ~Nov 2023 · 14 months · monthly snapshot~Nov 2023 – ~Feb 2024 · 3 months · monthly snapshot~Feb 2024 – ~Jul 2024 · 5 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Feb 2026 · 17 months · monthly snapshot~Feb 2026 – present · 5 months · monthly snapshot

Change History

17 versions recorded

  1. Feb 2026 — Present [monthly]

    Unknown PHASE3

    Status: Active Not Recruiting → Unknown

  2. Sep 2024 — Feb 2026 [monthly]

    Active Not Recruiting PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Active Not Recruiting PHASE3

  4. Feb 2024 — Jul 2024 [monthly]

    Active Not Recruiting PHASE3

    Status: Unknown Status → Active Not Recruiting

  5. Nov 2023 — Feb 2024 [monthly]

    Unknown Status PHASE3

    Status: Active Not Recruiting → Unknown Status

▶ Show 12 earlier versions

  1. Sep 2022 — Nov 2023 [monthly]

    Active Not Recruiting PHASE3

    Status: Recruiting → Active Not Recruiting · Phase: PHASE2_PHASE3 → PHASE3

  2. Oct 2021 — Sep 2022 [monthly]

    Recruiting PHASE2_PHASE3

  3. Jan 2021 — Oct 2021 [monthly]

    Recruiting PHASE2_PHASE3

  4. Dec 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  5. Jan 2020 — Dec 2020 [monthly]

    Recruiting PHASE2_PHASE3

  6. Aug 2019 — Jan 2020 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Active Not Recruiting → Recruiting

  7. Jul 2019 — Aug 2019 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: Not Yet Recruiting → Active Not Recruiting

  8. Jan 2019 — Jul 2019 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  9. Dec 2018 — Jan 2019 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  10. Jun 2018 — Dec 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  11. Apr 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  12. Jan 2018 — Apr 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • NeuroRx, Inc.
  • Target Health Inc.
Data source: NeuroRx, Inc.

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

Study Locations