Actively Recruiting
Ketamine Augmentation of ECT in Treatment-Resistant Depression
Led by Università Vita-Salute San Raffaele · Updated on 2026-05-11
30
Participants Needed
1
Research Sites
59 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Ketamine Augmentation of ECT in Treatment-Resistant Depression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects ages 18-70
- Diagnosed with major depressive disorder according to SCID5-CV interview
- Treatment resistant, defined as failure to respond to at least 2 different antidepressant agents
- Ability to provide informed consent
- Adequate score for anesthesia
You will not qualify if you...
- Chronic neurological diseases
- Intellectual disability
- Contraindications to electroconvulsive therapy, including severe aortic valve stenosis, implantable cardiac defibrillators, uncontrolled hypertension, significant respiratory, renal or hepatic disease, abdominal aortic aneurysm, endocrine disorders, neuromuscular diseases, brain lesions, or stroke within the last 6 months
- History of alcohol use disorder, substance use disorder, or substance abuse in the past year
- Pregnancy or lactation
- Cardiovascular conditions
- Psychiatric disorders other than MDD
- Hepatic impairment
- Known hypersensitivity to ketamine or its components
- Contraindications to ketamine use such as severe cardiovascular conditions, intracranial hypertension, or severe liver impairment
AI-Screening
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Trial Site Locations
Total: 1 location
1
IRCCS Ospedale San Raffaele Turro
Milan, Italy, 20127
Actively Recruiting
Research Team
A
Alberto AZ Zangrillo, MD
CONTACT
C
Cristina CC Colombo, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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