Double-blind, randomised, placebo-controlled early Phase I trial (n=30) testing a single low-dose IV ketamine 0.2 mg/kg (min 10 mg, max 20 mg) versus saline in adolescents (12–18) with treatment-resistant depression and suicidal ideation in the emergency department.
Randomised, quadruple-blind, placebo-controlled parallel-group trial enrolling adolescents aged 12–18 with treatment-resistant depression and suicidal ideation presenting to the ED; participants randomised 1:1 to ketamine 0.2 mg/kg IV or matched saline.
Study drug given over 2 minutes with vital-sign monitoring before and 5 minutes after infusion and continuous pulse oximetry for 30 minutes; assessments of depression and suicidal ideation at baseline, 1 hour, 3 hours, 1 day, 3 days, and 7 days.
Investigational Drug Service prepares identical syringes; the pharmacist is unmasked to preserve blinding for treating staff, research staff and outcomes assessors are masked.
Single low-dose IV ketamine 0.2 mg/kg (min 10 mg, max 20 mg).
Minimum 10 mg, maximum 20 mg; infusion over 2 minutes; nurse remains for 5 minutes; oximetry 30 minutes.
Normal saline in matched syringe (placebo comparator).
Normal saline in matched syringe; prepared by pharmacy to preserve blinding.