CTIS2024-512210-18-00
Active, not recruiting
Phase 1
A prospective randomized, single blind, controlled, safety and non-inferiority study of esketamine plus propofol compared to methohexital anesthesia for electroconvulsive therapy
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- major depression
- Sponsor
- Medical University Of Vienna
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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Comparison of anesthesia with methohexital to anesthesia with a mixture of propofol and ketamin for electroconvulsive therapysevere uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]EUCTR2021-003676-13-ATMedical University of Vienna100