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.
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University of TexasThe University of Texas is conducting research with psychedelics across locations in Houston, Austin, Dallas and San Antonio.