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Taking people in ItalyPhase 3

Testing ketamine added to electroconvulsive therapy for treatment-resistant depression

Tests whether ketamine added to electroconvulsive therapy helps adults with hard-to-treat depression.

Key facts

Who runs it
Università Vita-Salute San Raffaele
Where
Milan, ItalySee the site
Trial code
Registry title
Ketamine Augmentation of ECT in Treatment-Resistant Depression
Status
Recruiting
Phase
Phase 3
People taking part
30 people, planned
Started
10 Jul 2025
Planned end
Sept 2026
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Ketamine Hydrochloride
  • Placebo
Record updated
11 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for hospitalized adults aged 18-70 with major depressive disorder that has not improved with at least 2 antidepressants. They will get ECT with either ketamine or placebo.

Age
18 to 70 years
Sex
Men and women can join.
Disease stage
Major depressive disorder (checked with the SCID5-CV interview) that is treatment resistant.
Earlier treatment
At least 2 different antidepressant drugs used without success.

Main reasons for not taking part

  • Chronic neurological disease or intellectual disability
  • Conditions that make ECT unsafe, such as severe aortic valve stenosis, an implanted cardiac defibrillator or a stroke in the last 6 months
  • Alcohol or substance use disorder or substance abuse in the past year
  • Pregnancy or breastfeeding
  • Allergy or other reasons ketamine cannot be used

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Chronic neurological diseases,
  • 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,
  • 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
  • Intellectual disability
  • Pregnancy and lactation

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Italy

  • IRCCS Ospedale San Raffaele TurroMilan, ItalyContact: Alberto AZ Zangrillo, MDTaking people

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • KetamineTreatment being tested

    Patients receive standard ECT treatment combined with intravenous ketamine at a subanesthetic dose of 0.5 mg/kg, administered after induction with Propofol. Ketamine is administered during ECT sessions 2, 4, and 6. Intervention: * Drug: Ketamine * Dose: 0.5 mg/kg IV * Timing: ECT sessions 2, 4, and 6 * Background: Investigating the additive antidepressant and potential cognitive-protective effects of ketamine in patients with treatment-resistant depression undergoing ECT.

    Treatment: Ketamine Hydrochloride

  • PlaceboPlacebo, for comparison

    Patients receive standard ECT treatment combined with placebo (0.9% sodium chloride solution), administered intravenously after induction with Propofol, during ECT sessions 2, 4, and 6, mimicking the ketamine group's schedule. Intervention: * Drug: Saline solution (NaCl 0.9%) * Timing: ECT sessions 2, 4, and 6 * Background: Serves as control to assess the specific contribution of ketamine to antidepressant efficacy and cognitive outcomes.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study
Plain-language title
Testing ketamine added to electroconvulsive therapy for treatment-resistant depressionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07088380, who can take part
Record updated
11 May 2026