Adding ketamine to ECT for treatment-resistant depression

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled Phase 3 trial comparing IV ketamine versus saline given during electroconvulsive therapy (ECT) in hospitalized adults with treatment-resistant major depressive disorder. Thirty patients aged 18–70 who have failed at least two antidepressant medications will be randomized to receive ketamine or placebo during ECT sessions 2, 4, and 6. The primary outcome is change in depressive symptoms measured by the MADRS at 4 weeks, and cognitive side effects will also be tracked. The trial is conducted at IRCCS Ospedale San Raffaele Turro in Milan under standard anesthesia and ECT protocols.

Why it matters

Who can join: the full rules

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 it's running

• IRCCS Ospedale San Raffaele Turro
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Alberto AZ Zangrillo, MD — Università Vita-Salute San Raffaele
• Study coordinator: Alberto AZ Zangrillo, MD
• Email: zangrillo.alberto@hsr.it
• Phone: 0226436154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.