This double-blind, placebo-controlled trial (n=24) aims to evaluate the effectiveness of ketamine treatment compared to midazolam over three consecutive days in patients with difficult-to-treat depression.
Randomised, double-blind, parallel-group trial in adults with depression (MADRS ≥25) comparing IV ketamine 0.5 mg/kg (40-minute infusion) versus midazolam 0.045 mg/kg, administered once daily for three consecutive days; primary outcomes include change in MADRS with follow-up at 1 and 4 weeks.
Safety and secondary measures include vital signs, dissociative symptoms, CGI and EQ-5D-5L; eligibility requires prior adequate trials of antidepressants and psychotherapy and excludes recent substance use disorder, psychosis, bipolar disorder, pregnancy and several serious medical conditions.
IV ketamine 0.5 mg/kg infused over 40 minutes once daily for 3 consecutive days.
40-minute infusion per session
IV midazolam 0.045 mg/kg infused over 40 minutes once daily for 3 consecutive days (placebo comparator per registry).
Midazolam 0.045 mg/kg; 40-minute infusion