deltatrials
Terminated PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT05144685

A Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic

A Randomized, Double Blind Controlled Study to Evaluate the Safety and Effectiveness of a Digital Therapeutic for Individuals With Suicidal Ideation and/or Suicide Attempts

Sponsor: National Institute of Mental Health (NIMH)

Conditions Suicidal Ideation Suicide, Attempted
Interventions OTX-000 OTX-202 Treatment as Usual
Updated 11 times since 2022 Last updated: Jun 10, 2025 Started: Apr 7, 2022 Primary completion: Jun 14, 2024 Completion: Jun 14, 2024
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Data Safety Monitoring Board (DSMB) recommendation per Charter stopping rules. The study surpassed the pre-planned futility boundary.

Other terminated trials from National Institute of Mental Health (NIMH)

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This PHASE2/PHASE3 trial investigates Suicidal Ideation and Suicide, Attempted and is currently terminated or withdrawn. National Institute of Mental Health (NIMH) leads this study, which shows 11 recorded versions since 2022 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2022 – ~Mar 2022 · 59 days · monthly snapshotNot Yet Recruiting~Mar 2022 – ~Apr 2022 · 31 days · monthly snapshotNot Yet Recruiting~Apr 2022 – ~May 2022 · 30 days · monthly snapshotNot Yet Recruiting~May 2022 – ~Feb 2023 · 9 months · monthly snapshotEnrolling By Invitation~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshotEnrolling By Invitation~Mar 2023 – ~Sep 2023 · 6 months · monthly snapshotEnrolling By Invitation~Sep 2023 – ~Jul 2024 · 10 months · monthly snapshotEnrolling By Invitation~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotEnrolling By Invitation~Sep 2024 – ~Feb 2025 · 5 months · monthly snapshotEnrolling By Invitation~Feb 2025 – ~Jul 2025 · 5 months · monthly snapshotTerminated~Jul 2025 – present · 14 months · monthly snapshotTerminated

Change History

11 versions recorded

  1. Jul 2025 — Present [monthly]

    Terminated PHASE2/PHASE3

  2. Feb 2025 — Jul 2025 [monthly]

    Terminated PHASE2/PHASE3

    Status: Enrolling By Invitation → Terminated

  3. Sep 2024 — Feb 2025 [monthly]

    Enrolling By Invitation PHASE2/PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Enrolling By Invitation PHASE2/PHASE3

    Phase: PHASE2_PHASE3 → PHASE2/PHASE3

  5. Sep 2023 — Jul 2024 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

▶ Show 6 earlier versions

  1. Mar 2023 — Sep 2023 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  2. Feb 2023 — Mar 2023 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

  3. May 2022 — Feb 2023 [monthly]

    Enrolling By Invitation PHASE2_PHASE3

    Status: Not Yet Recruiting → Enrolling By Invitation

  4. Apr 2022 — May 2022 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  5. Mar 2022 — Apr 2022 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    Phase: NA → PHASE2_PHASE3

  6. Jan 2022 — Mar 2022 [monthly]

    Not Yet Recruiting NA

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • National Institute of Mental Health (NIMH)
  • Oui Therapeutics, Inc.
Data source: Oui Therapeutics, Inc.

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

Study Locations