NCT07088380RecruitingPhase 3
Ketamine Augmentation of ECT in Treatment-Resistant Depression
The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 8 Jul 2025
- Start date
- 10 Jul 2025
- Primary completion date
- Aug 2026
- Lead sponsor
- Università Vita-Salute San Raffaele
- Diseases
- Depression
- NCT number
- NCT07088380
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 30
- From 10 Jul 2025 to the primary completion date, Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- Intellectual disability
- Pregnancy and lactation
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Ospedale San Raffaele Turro Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.