Ketamine Augmentation of ECT in Treatment-Resistant Depression

Launched by UNIVERSITÀ VITA-SALUTE SAN RAFFAELE · Jul 18, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether adding a medicine called ketamine to electroconvulsive therapy (ECT) can help people with major depression that has not improved after trying at least two different antidepressant treatments. ECT is a procedure that uses electrical currents to trigger a brief seizure in the brain and is often used when other treatments haven’t worked. The researchers want to see if ketamine can make ECT work better to reduce depression symptoms and also help lessen memory or thinking problems that sometimes happen after ECT.

The study will include adults aged 18 to 70 who have been diagnosed with treatment-resistant major depression and are able to safely receive anesthesia and ECT. People with certain health problems, such as serious heart issues, brain disorders, or recent substance abuse, will not be able to participate. If you join the study, you will be randomly assigned to receive either ketamine or a placebo (a saltwater solution) during some of your ECT sessions. Your depression symptoms will be closely monitored over four weeks to see how well the treatment works. This study is not yet enrolling participants, but it hopes to provide new information about improving depression treatment for people who have not found relief with standard medications.

Gender

ALL

Eligibility criteria

• 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.