Clinical Trial

Ketamine Augmentation of ECT in Treatment-Resistant Depression

Study acronym: Ketamina
Recruiting Phase 3
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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-Åsberg Depression Rating Scale (MADRS) at 4 weeks.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2025-07-18; most recent amendment 2026-05-05.
Status change: Not Yet Recruiting → Recruiting 2025-07-27
Trial Details
NCT Number NCT07088380
Lead Sponsor Università Vita-Salute San Raffaele
Conditions Major Depressive Disorder, Treatment Resistant Depression
Enrollment 30 participants
Start Date 2025-07-10
Primary Completion 2026-08 (estimated)
Study Completion 2026-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-11