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RecruitingPhase 3

Ketamine Augmentation of ECT in Treatment-Resistant Depression

NCT07088380 · Ketamina · Università Vita-Salute San Raffaele

Recruiting
Status
Accepting participants
Phase 3
Phase
30
Target enrolment
1
Study sites
Outside the US

What it is testing

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.

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

  • Mean change in depressive symptoms, as measured by MADRS scale

    Measured over From baseline (day 0) to day 28 (7 days after the last ECT session). A follow-up assessment at Week 12 (90 days) will be included

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 70 Years
Ages
All
Sex
Not accepted
Healthy volunteers
Inclusion Criteria: * Male and female subjects ages 18-70, * diagnosed with MDD (according to SCID5-CV interview) * treatment resistant (defined as at least 2 different antidepressant agents used without success), * ability to give informed consent, * adequacy of the score for anesthesia. Exclusion Criteria: * Chronic neurological diseases, * Intellectual disability * Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, space occupying brain lesions, stroke in the last 6 months), * Patients with Alcohol Use Disorder or Substance Use Disorder or Substance Abuse history in the past year, * Pregnancy and lactation * Cardiovascular conditions, * Psychiatric Disorders, * Hepatic impairment, * Participants with a known hypersensitivity to ketamine or any of its excipients will be excluded from the study, * Participants with any contraindications to the use of ketamine, such as a history of severe cardiovascular conditions (e.g., uncontrolled hypertension, significant arrhythmias), intracranial hypertension, or severe liver impairment, will also be excluded to prevent potential adverse events.

Where

1 study site

FacilityCityRegionCountry
IRCCS Ospedale San Raffaele TurroMilanItaly

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

Before you do, the preparation checklist lists what a site will ask you on a first call and what is worth asking them. It is free and collects nothing.

NCT07088380 on ClinicalTrials.gov →

Last updated in the registry 2026-05-11. Registry records change; this page reflects the data build of 2026-08-25.

Related

Where this trial sits