This parallel assignment, single-blind clinical trial (n=396) evaluates IV esketamine (0.25 mg/kg) versus saline prior to modified electroconvulsive therapy (MECT) for patients with severe depression.
Multicentre, randomised, single-blind, parallel-group trial comparing intravenous esketamine 0.25 mg/kg to saline control given before propofol/succinylcholine anaesthesia and MECT in patients with major depression (HDRS-24 ≥35).
Primary outcome is remission rate after MECT defined as two consecutive HDRS-24 scores ≤10. Sample size 396 (198 per arm) accounting for 20% dropout; allocation 1:1.
IV esketamine 0.25 mg/kg given prior to MECT with propofol and succinylcholine.
Given IV sequentially; co-administered propofol 1.5 mg/kg and succinylcholine 1 mg/kg prior to ECT.
Saline 0.05 ml/kg given prior to MECT with propofol and succinylcholine (sham comparator).
Normal saline 0.05 ml/kg; co-administered propofol 1.5 mg/kg and succinylcholine 1 mg/kg prior to ECT.