Randomised, parallel-group non-inferiority trial (n=198) comparing racemic ketamine IV infusions (0.5 mg/kg over 40 minutes, thrice weekly) with ECT in inpatients with severe MDD.
This randomised, parallel-group trial enrolled inpatients (18–85 years) with severe major depressive disorder who had been offered and accepted ECT to compare IV ketamine with standard ECT.
Experimental treatment consisted of racemic ketamine 0.5 mg/kg infused IV over 40 minutes, administered thrice weekly; the comparator arm received ECT per local standard procedures (anaesthesia and muscle relaxation included).
Primary outcome was remission (MADRS ≤10) after 4 weeks; secondary assessments included response/remission at 3, 6 and 12 months, cognitive testing (CANTAB), and biomarker analyses from blood samples.
Racemic ketamine IV infusions (0.5 mg/kg) administered over 40 minutes, thrice weekly.
Infusion delivered over 40 minutes.
Electroconvulsive therapy given in line with standard procedures (including anaesthesia, muscle relaxation and oxygenation) thrice weekly.
Standard ECT procedure; anaesthetic and stimulation parameters per local practice.