Last updated: March 12, 2024
Sponsor: Medical University of Vienna
Overall Status: Active - Recruiting
Phase
4
Condition
Depression
Treatment
Ketofol
Methohexital
Clinical Study ID
NCT05655754
BMF22114
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 ofAnesthesiologists ASA ≤ 3)
- antidepressant and antipsychotic medication in steady state for at least 7 days priorto first ECT treatment
Exclusion
Exclusion Criteria:
- severe somatic or neurological disease (esp. current or previous history ofintracranial 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 routinelaboratory screening
- pregnancy, breast feeding
- known allergy to the study drugs or compounds of the latter
Study Design
Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Ketofol
Phase: 4
Study Start date:
November 01, 2022
Estimated Completion Date:
October 31, 2025
Connect with a study center
Pia Baldinger-Melich
Vienna, 1090
AustriaActive - Recruiting
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