A prospective randomized, single blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy

Prior treatment

• severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction)

Other illness

• current or past history of schizophrenia or schizoaffective disorder
• known allergy to the study drugs or compounds of the latter

Lab values

• clinical relevant abnormalities on a general physical examination and routine laboratory screening

Other

• pregnancy, breast feeding

• male or female inpatients
• age ≥ 18 years
• ICD-11 diagnosis of severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
• Hamilton Depression Rating Scale HAMD17 ≥ 24
• ability to understand and willingness to sign written informed consent document
• negative urine pregnancy test in women
• anesthesiological approval for ECT (Classification of the American Society of Anesthesiologists ASA ≤ 3)
• antidepressant and antipsychotic medication in steady state for at least 7 days prior to first ECT treatment