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Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 8 months later Apr 30, 2026 → Dec 31, 2026
See other at-risk trials from The University of Texas Health Science Center at San Antonio

Record History

See every version on ClinicalTrials.gov ↗

  1. Notable Primary completion pushed from Apr 30, 2026 to Dec 31, 2026
    • Study completion pushed from Dec 31, 2026 to Jun 30, 2027
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: details revised at 3 of 3 entries
  2. Notable Primary completion date: Apr 2025 to Apr 30, 2026
    • Study completion date: Dec 2026 to Dec 31, 2026
    v4
  3. Notable Primary completion date: Apr 2024 to Apr 2025
    • Study completion date: Dec 2025 to Dec 2026
    v3
  4. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 2023 to Jan 6, 2023
    • Collaborators expanded, about 7 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this randomized pilot trial is to assess the feasibility of administering a combination of 100mg intramuscular (IM) ketamine and Crisis Response Plan (a short psychosocial intervention) for patients with acute suicidality in the context of the Emergency Department setting. This study will assess a combination of a pharmacologic intervention and a psychosocial one. The pharmacologic intervention is a one-time dose of 100mg ketamine delivered intramuscularly (IM) while the patient is in the ED. The psychosocial intervention under study is a brief, patient-centered therapy which takes, on average, 30 minutes to administer. Both interventions will be administered only once. The main questions this study aims to answer are: * Determine if 100mg of IM ketamine and Crisis Response Plan in combination results in greater short-term reductions in suicidal ideation in adult patients who report acutely elevated suicide risk during an ED visit. * Examine potential weight-based dose response differences in the reductions in suicidal ideation to determine if future treatment protocols with IM ketamine may benefit from weight-based dosing.
Trial Details
NCT Number NCT05696691
Lead Sponsor The University of Texas Health Science Center at San Antonio
Collaborators: National Center for Advancing Translational Sciences (NCATS)
Conditions
(from sponsor)
Suicide
Related terms Emergencies, Suicidal Ideation, Suicide
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov