severe uni- or bipolar depression (F32.2, F32.2, F33.2, F33.3, F31.4, F31.5)
Conditions
Interventions
Trade Name: Brevimytal
Product Name: Brevimytal
Pharmaceutical Form: Powder for solution for injection/infusion
INN or Proposed INN: Methohexital Sodium
CAS Number: 22151-68-4
Other descriptive name:
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion 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: 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The present study is designed as a prospective randomized non-inferiority trial comparing a combination of esketamine and propofol, ratio 1:1[36, 37]) to methohexital. H1: Improvement of depressive symptoms as documented using HAMD17 following a course of ECT (8 bilateral treatment sessions) will be non-inferior in the esketamine/propofol group compared to the methohexital group (non-inferiority margin for intra-individual HAMD17 score change from baseline to week 5 (post-ECT): 5, NB: HAMD17 maximum score = 52) H2: The recovery time (from induction of anesthesia until discharge, more specifically until an Aldrete-score [38] = 6 is reached) will be non-inferior in the ketofol group compared to the methohexital group (non-inferiority margin for recovery time: 6 min, calculated as mean of the 8 ECT sessions (previous data: mean recovery time 28 min). ;Secondary Objective: H3: The total use of concomitant medication to treat postictal hypertension, tachycardia and agitation per treatment arm H4: Esketamine/propofol anesthesia will be non-inferior to methohexital use in terms of the final stimulus charge (surrogate for seizure quality) applied during ECT H5: change of cognitive outcomes (7 tests including MMSE), H6: average time to reorientation (TRO) over 8 ECT sessions in both treatment arms. H7: We will assess changes of blood pressure and heart rate between induction of anesthesia and immediately following seizure cessation (postictal), the occurrence of agitation during recovery (assessing changes in RASS score between induction of anesthesia and recovery) and change of markers of cardiac injury (pro-BNP, troponin T, CK-MB) before and after each ECT session. H8: , laboratory markers of liver injury (ALT, AST, gamma-GT, albumin, normotest) will be monitored at baseline, at the 4th ECT session and at termination of the course.;Primary end point(s): HAMD17 following a course of ECT (8 bilateral treatment sessions) Recovery time (from induction | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Endpoints will be evaluated after a total of 8 ECT sessions;Secondary end point(s): -cumulative concomitant medication -final stimulus charge applied during ECT -cognitive outcomes - time to reorientation (TRO) -blood pressure and heart rate from preictal to postictal -change in RASS score from pre-induction to recovery -change of markers of cardiac injury (pro-BNP, troponin T, CK-MB) before and after each ECT session. -changes of laboratory markers of liver injury ALT, AST, gamma-GT, albumin, normotest | — |
Countries
Austria
Contacts
Public ContactDepartment of Psychiatry
Medical University of Vienna
Outcome results
None listed