The additive effect of ketamine in combination with electroconvulsive stimulation (ECS) in major depressive disorder (MDD): a translational study

Other illness

• 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

Other

• Intellectual disability
• Pregnancy and lactation

• 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.