Comparison of anesthesia with methohexital to anesthesia with a mixture of propofol and ketamin for electroconvulsive therapy

Phase 1

• Conditions: severe 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]

• Registration Number: EUCTR2021-003676-13-AT
• Lead Sponsor: Medical University of Vienna

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-02
• Last Update Posted: 8 August 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 85
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified