A prospective randomized, single blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy
- Conditions
- major depressionTherapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]
- Registration Number
- CTIS2024-512210-18-00
- Lead Sponsor
- Medical University Of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 100
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
severe somatic or neurological disease (esp. current or previous history of intracranial hypertension, uncontrolled severe hypertension, bleeds or aneurysm, recent myocardial infarction), current or past history of schizophrenia or schizoaffective disorder, clinical relevant abnormalities on a general physical examination and routine laboratory screening, pregnancy, breast feeding, known allergy to the study drugs or compounds of the latter
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method