Ketamine & Crisis Response Plan for Suicidal Ideation in the ED

This Phase II/III randomized pilot trial (n=24) conducted by The University of Texas Health Science Center at San Antonio aims to assess the feasibility of administering 100mg intramuscular (IM) ketamine alongside a Crisis Response Plan for patients with acute suicidal ideation in the Emergency Department.

The trial will randomize participants into two groups: one receiving IM ketamine plus CRP (intervention group) and the other receiving usual care (control group). The study will evaluate whether this combination results in greater short-term reductions in suicidal ideation compared to usual care.

The primary outcome measures include the feasibility of the study interventions, such as the number of enrolled subjects completing treatment within study parameters, with safety and side-effect profiles, and changes in suicidal ideation scores.

Participants, aged between 18 and 70, will undergo assessments at baseline, 2 hours post-treatment, 3 days, and 1 month after the intervention. Individuals presenting with acute suicidal ideation and cleared for admission to the University Hospital inpatient psychiatric unit are eligible for participation. The study started in January 2023, and the estimated primary completion is in April 2024, with the overall study completion expected by December 2025.

Trial Details

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.

NCT Number NCT05696691

Data attribution

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