Overview

Ketamine Augmentation of ECT in Treatment-Resistant Depression

Status:
RECRUITING
Trial end date:
2026-02-01
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, placebo-controlled phase 3 clinical trial evaluating the additive effect of intravenous ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant major depressive disorder (MDD). The study aims to determine whether ketamine enhances the antidepressant efficacy of ECT and reduces associated cognitive side effects. Thirty hospitalized patients diagnosed with treatment-resistant MDD will be randomized to receive either ketamine or placebo (saline) during ECT sessions 2, 4, and 6. Primary outcome is the change in depressive symptoms, measured by the Montgomery-sberg Depression Rating Scale (MADRS) at 4 weeks.
Phase:
PHASE3
Details
Lead Sponsor:
Universit Vita-Salute San Raffaele
Treatments:
Ketamine