delirium Interictal delirium
Conditions
Interventions
Both study arms will receive standard hospital care troughout the trial.
Each patient who signed informed consent and meets the criteria for interictal
delirium will be randomized to one of both tr
Cognitive advserse effects
delirium
Electroconvulsive therapy
Rivastigmine
Sponsors
VUmc
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: First part (cohort) - Age: 55 years or older - 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;Adjuvant criteria for inclusion in the rivastigmine trial - Occurence of an interictal delirium is assessed by the Confusion Assessment method (CAM) and/ or 4 pts drop Mini Mental State Examination score (MMSE)
Exclusion criteria
Exclusion criteria: First part (cohort) - Patient does not meet the inclusion criteria - Patient has a comorbid medical condition that is a contraindication for ECT according to the prevailing Dutch ECT-guidelines - Prior participation in the study (e.g. in case of relapse of the depression requiring a new ECT course).;Adjuvant criteria for exclusion in the rivastigmine trial - 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 |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, Stroop Color Word Test, Rey Auditory Verbal Learning Test (=15-word learning test), fluency, clock drawing test, Kopelman Autobiographical Memory Interview, Visual Association Test (VAT) all assessed during ECT, and their determinants. 7. What is the Cost effectiveness of rivastigmine addition during ECT? For this purpose we assess the EQ-5D-5L at baseline, at the start of the trial and after ECT. | — |
Countries
The Netherlands
Outcome results
None listed