Interictal delirium during electric convulsive therapy- course
Conditions
Interventions
Trade Name: Rivastigmine
Product Name: Rivastigmine
Pharmaceutical Form: Transdermal patch
Pharmaceutical form of the placebo: Transdermal patch
Route of administration of the placebo: Transdermal use
Sponsors
GGZ inGeest, parner VUmc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patient is admited at the in-wards of one of the participating psychiatric hospitals - Patients fulfilling the Composite International Diagnostic Interview (CIDI) criteria of a Major Depressive Episode (not necessarily in the context of a Major Depressive Disorder only) - Patient is indicated for ECT-treatment. - Patient or legal representitive is able to give informed consent - Occurence of an interictal delirium is assessed by the Confusion Assessment method (CAM) and/ or 4 pts drop Mini Mental State Examination score (MMSE) 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 38 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 38
Exclusion criteria
Exclusion criteria: - Patients not meeting the inclusion criteria - Patient has a comorbid medical condition that is a contraindication for ECT according to the prevailing Dutch ECT-guidelines - Current use of rivastigmine or an other cholinesterase inhibitor - Known intolerance of rivastigmine or an other cholinesterase inhibitor - Bradycardia or AV conduction disorder at baseline ECG (first degree AV block exluded) - switch from right unilateral electrodeplacement (RUL) to bilateral electrodeplacement (BL) during trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): 1. Scores on Delirium Rating Scale (DRS-98), assessed after two ECT sessions with rivastigmine, compared with DRS-98 outcomes assessed after two ECT sessions without rivastigmine . 2. Scores on cognitive functioning tests (MMSE, fluency, clock-drawing-test), assessed after two ECT sessions with rivastigmine, compared with outcomes assessed after two ECT sessions without rivastigmine. NB baseline scores: mainained 48-24h before first ECT session within trial. ;Timepoint(s) of evaluation of this end point: Final scores will be obtained 1 day after the final ECT session in the trial ;Main Objective: The aim of this study is twofold. The main aim of this study is twofold. We aim to (1) investigate whether rivastigmine can be used as a novel treatment to reduce ECT-induced interictal delirium and (2) to gain further insight in the different types of cognitive disturbances induced by ECT and its correlates by creating a large cohort of ECT patients. ;Secondary Objective: To describe - influence rivastgmine on several ECT and anaesthetic parameters (sedation, medication use, reorientation time, effects on muscle relaxation, bloodpressure, etc) - tolerability of rivastigmine during ECT For differentiation into subtypes of confusional states and their determinants: - Profiles of confusional states based on scores on reorientation time, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, clock-drawing-test, all assessed during ECT, and their determinants. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 3.Impact of rivastigmine on several ECT characteristics (bloodpressure, heart rate, seizure length, post ictal supression index, seizure threshold, time of – anesthesia induced - muscle relaxation, type of anesthetics and dosage) measured during ECT. 4.Adverse/ side effects of rivastigmine. For differentiation into subtypes of confusional states and their determinants: 5. Profiles of confusional states based on scores on reorientation time, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, clock-drawing-test, all assessed during ECT, and their determinants. ;Timepoint(s) of evaluation of this end point: Final scores for secondary endpoint will be obtained 1 day maximum after the final ECT session in the trial | — |
Countries
Netherlands
Contacts
Public Contactopname ouderen
GGZ inGeest, partner van VUmc
Outcome results
None listed