NCT07088380

Ketamine Augmentation of ECT in Treatment-Resistant Depression

The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Università Vita-Salute San Raffaele · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder
• Treatment Resistant Depression

Interventions

Type	Name	Description
DRUG	Ketamine Hydrochloride	Ketamine will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.
DRUG	Placebo	Placebo will be administered intravenously at a subanesthetic dose of 0.5 mg/kg after a bolus of Propofol, during ECT sessions 2, 4, and 6.

Timeline

• Start date: 2025-07-10
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2025-07-28
• Last updated: 2025-07-29

Locations

1 site across 1 country: Italy