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Ketamine Augmentation of ECT in Treatment-Resistant Depression

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…

ClinicalTrials.gov IDNCT07088380

PhasePHASE3

Enrollment30

SponsorUniversità Vita-Salute San Raffaele

Age18 Years

SexALL

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Conditions studied

Major Depressive Disorder, Treatment Resistant Depression

About this study

Interventions

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.

Primary outcomes

Mean change in depressive symptoms, as measured by MADRS scale (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)

Eligibility information

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.

Study locations

IRCCS Ospedale San Raffaele Turro, Milan, 20127 Italy

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.