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The Effectiveness and Safety of Esketamine in Modified Electroconvulsive Therapy

Unknown statusRegisteredCTG

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.

Details

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.

Topics:Major Depressive Disorder (MDD)

Registry

Registry linkNCT04777110