Multicentre, randomised, non-inferiority, parallel-group open-label trial (n=340) comparing six adjunctive IV esketamine infusions (0.2 mg/kg, 40-minute infusion, three times/week) versus six ECT sessions over two weeks for reduction of suicidal ideation in depressive episodes.
This multicentre randomised non-inferiority trial will enrol 340 adults with depressive episodes and clinically significant suicidal ideation to compare adjunctive intravenous esketamine (six 0.2 mg/kg infusions over two weeks) with electroconvulsive therapy (six sessions over two weeks).
Primary outcome is remission of suicidal ideation (SSI <4) at end of the two-week intervention. Secondary and exploratory outcomes include depression severity, cognition, quality of life, social functioning, safety, and mechanistic biomarker assessments including blood/urine/feces analyses, multimodal MRI, and EEG.
Six adjunctive IV esketamine infusions over two weeks (three times/week).
Infusion diluted in 0.9% NaCl; minimum infusion duration 40 minutes; fasting 8 hours prior.
Six ECT sessions over two weeks (three times/week).
Electroconvulsive therapy (ECT) with unilateral electrode placement; anaesthesia and muscle relaxant per protocol; pre-session fasting and bladder evacuation.