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Clinical Trials/EUCTR2021-003676-13-AT
EUCTR2021-003676-13-AT
Active, not recruiting
Phase 1

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

Medical University of Vienna0 sites100 target enrollmentJune 2, 2022

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
Sponsor
Medical University of Vienna
Enrollment
100
Status
Active, not recruiting
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 2, 2022
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • \-male or female inpatients
  • \-age \= 18 years
  • \-ICD\-10 diagnosis of severe uni\- or bipolar depression (F32\.2, F32\.2, F33\.2, F33\.3, F31\.4, F31\.5\)
  • \-HAMD17 \= 24
  • ability to understand and willingness to sign written informed consent document
  • \-antidepressant and antipsychotic medication in steady state for at least 7 days prior inclusion
  • \-negative urine pregnancy test in women
  • \-anesthesiological approval for ECT (ASA \= 3\)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:

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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