Randomised, quadruple-blind, parallel-arm trial (n=24) testing a single IV ketamine infusion (0.5 mg/kg, 40 min) versus midazolam (0.45 mg/kg, 40 min) for rapid reduction of suicidal ideation in adults hospitalized or presenting with SI.
This randomised, parallel-arm, quadruple-blind study compared a single sub-anesthetic IV dose of ketamine (0.5 mg/kg) to an active anesthetic control (midazolam 0.45 mg/kg), each infused over 40 minutes, in adults with clinically significant suicidal ideation.
Primary aims were feasibility, tolerability, and rapid anti-suicidal efficacy, with outcomes assessed acutely and within 24 hours; participants continued standard psychiatric treatment throughout the trial.
The trial enrolled 24 participants aged 18–80 at Icahn School of Medicine at Mount Sinai; midazolam was chosen to preserve blinding by producing transient subjective effects without expected sustained antidepressant benefit.
Single IV infusion of ketamine 0.5 mg/kg over 40 minutes.
Infused over 40 minutes.
Single IV infusion of midazolam 0.45 mg/kg over 40 minutes (anesthetic control).
Midazolam 0.45 mg/kg infused over 40 minutes (anesthetic control; named in notes).