Randomised, quadruple-blind, crossover adolescent trial (n=17 actual) assessing single IV ketamine (0.5 mg/kg) versus active midazolam (0.045 mg/kg) for medication-refractory MDD or anxiety disorders with 2-week washout.
Randomised, quadruple-blind, crossover trial in adolescents with medication-refractory major depressive disorder or anxiety disorders (actual N=17). Participants received a single IV infusion of ketamine (0.5 mg/kg) or midazolam (0.045 mg/kg) with a 2-week washout between sessions.
Primary outcomes are change in MADRS score (MDD cohort) and change in MASC acute physical symptoms subscale (anxiety cohort) at 1 day post-infusion; safety/tolerability monitored during infusion and for hours afterwards.
Single IV ketamine 0.5 mg/kg; crossover with midazolam; 2-week washout.
IV infusion over 40 minutes; max total dose 50 mg; monitored hourly for 3 h post-infusion.
Single IV midazolam 0.045 mg/kg as active comparator.
IV infusion over 40 minutes; max total dose 4.5 mg; active control (Versed).