Testing ketamine added to electroconvulsive therapy for treatment-resistant depression
Tests whether ketamine added to electroconvulsive therapy helps adults with hard-to-treat depression.
Plain-language title generated from the registry record
Registry title: Ketamine Augmentation of ECT in Treatment-Resistant Depression
Key facts
- Where
- Milan, ItalySee the site
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT07088380, who can take part
Where in Italy
- IRCCS Ospedale San Raffaele TurroMilan, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Università Vita-Salute San Raffaele
- Trial code
- NCT07088380
- Record updated
- 11 May 2026
- Original description
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.Read full original descriptionShow less
The Additive Effect of Ketamine in Combination With ElectroConvulsive Stimulation (ECS) in Major Depressive Disorder (MDD): a Translational Study
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.
Inclusion: 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: 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.