Parallel randomized double-blind trial of a single IV infusion of ketamine 0.5 mg/kg vs midazolam 0.045 mg/kg (active placebo) in adults 20–65 with treatment-resistant depression and prominent suicidal ideation. Target enrollment: 48. Primary outcome: rate of reduction in suicide symptoms post-infusion. Conducted at Taipei Veterans General Hospital, Taiwan. Funded by the Ministry of Science and Technology.
Single IV infusion of ketamine 0.5 mg/kg over 40 minutes
Low-dose IV infusion over 40 minutes
Single IV infusion of midazolam 0.045 mg/kg over 40 minutes (active placebo)
Midazolam 0.045 mg/kg IV over 40 minutes (active placebo)
In this randomized double‑blind trial of 84 outpatients with treatment‑resistant depression and prominent suicidal ideation, a single low‑dose ketamine infusion (35mg/70kg) produced greater antidepressant effects than midazolam lasting up to 14 days and antisuicidal effects lasting about 5 days. Benefits were most evident in patients whose current episode was under 24 months or who had failed ≤4 antidepressants, and the infusion was safe and well tolerated.