This Phase III, double-blind, randomised, placebo-controlled trial (n=30) will study the effects of intravenous ketamine (35mg/70kg) given during electroconvulsive therapy (ECT) sessions 2, 4, and 6 in adults with treatment-resistant major depressive disorder (MDD).
Conducted by Università Vita-Salute San Raffaele in Milan, Italy, this study aims to determine whether ketamine can boost the antidepressant effects of ECT and reduce the cognitive side effects sometimes associated with the procedure. Participants are hospitalised adults aged 18–70 who have not responded to at least two different antidepressant medications. They will be randomly assigned to receive either ketamine or a placebo saline solution, both administered after induction with propofol.
The main outcome will be changes in depression severity, measured by the Montgomery–Åsberg Depression Rating Scale (MADRS) at four weeks. Secondary measures will assess suicidal thoughts, anxiety symptoms, cognitive function, dissociation, psychotic symptoms, and neurochemical markers in the blood. Follow-up assessments will be conducted three months after the final ECT session to evaluate the longer-term effects of the intervention.
Trial Details
Trial Number
Measures Used
Montgomery-Asberg Depression Rating ScaleA ten-item diagnostic questionnaire used to measure the severity of depressive symptoms in patients with mood disorders.