The additive effect of ketamine in combination with electroconvulsive stimulation (ECS) in major depressive disorder (MDD): a translational study
Key facts
- Where
- Milan, OlaszországSee the site
- Phase
- 3. fázis
Where in Olaszország
- Ospedale San Raffaele S.r.l.Milan, OlaszországTaking 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
- Universita' Vita-salute S. Raffaele
- Trial code
- EU 2024-512559-20-01
- Record updated
- 2026. március 2.
- Original description
The primary objective of this study is to evaluate the antidepressant effect of ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant depression.Read full original descriptionShow less
The primary objective of this study is to evaluate the antidepressant effect of ketamine in combination with electroconvulsive therapy (ECT) in patients with treatment-resistant depression.
Inclusion: Participant is willing and able to give informed consent for participation in the study; Male and Female, aged 18-70; Women of childbearing potential (WOCBP) must use at least 1 highly effective method of contraception. Highly effective methods of contraception are those which have a failure rate of <1% (when implemented consistently and correctly) and include: Intrauterine device (IUD), Bilateral tubal ligation, bilateral salpingectomy, or bilateral tubal occlusive procedure, Hormonal contraceptives (eg, oral, patch, or injectable), A double-barrier protection method (eg, condom, sponge, or vaginal diaphragm with spermicide cream, foam, or gel); abstinence from heterosexual intercourse is accepted if this is the participant’s usual lifestyle; Diagnosed with major depressive disorder (according to SCID5-CV scale); Affected by treatment resistant depression (defined as at least 2 different antidepressant agents used without success); Adequacy of the score for anesthesia.
Exclusion: Chronic neurological disease; 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; 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),; Contraindications to the electroconvulsive therapy (severe aortic valve stenosis, implantable cardiac defibrillators, implantable electronic devises, uncontrolled hypertension, clinically significant respiratory, renal or hepatic disease, abdominal aortic aneurism, endocrine disorders, neuromuscular disease, 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; Any other Psychiatric Disorders, other than MDD; Hepatic impairment; Intellectual disability; Pregnancy and lactation.