We propose a clinical trial of intramuscular ketamine in depressed ED patients with high-risk suicidality, which if successful would support a novel, easy-to-use, scalable intervention for busy emergency clinicians to implement.
Randomised, double-blind, parallel-group trial (2:1 ketamine:midazolam) in adults presenting to the psychiatric ED with suicidality; single IM injection of ketamine 0.5 mg/kg versus midazolam 0.06 mg/kg with monitoring and blood draws, admission for standard inpatient care, and follow-up to 4 weeks post-discharge.
Rationale: rapid reduction of suicidal ideation with subanesthetic ketamine may provide a scalable emergency intervention; biosamples (60 and 90 min) and genetic sample collected for mechanistic analyses.
Operational note: the NYSPI site is paused (institutional pause on human subjects research since June 2023) following an OHRP FWA restriction; other sites remain subject to local approvals.
IM ketamine 0.5 mg/kg single injection
Single IM injection; blood draws at 60 and 90 min; genetic sample stored.
IM midazolam 0.06 mg/kg single injection
Midazolam 0.06 mg/kg IM single injection (active comparator).