Cognitieve stoornissen Depression
Conditions
Interventions
Rivastigmine add-on treatment during ECT treatment.
Patients will receive either placebo or rivastigmine, randomised in a 1:1
ratio. Rivastigmine will be added to the ECT course: in the first two we
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Ageover 18 years - Clinical indication for ECT (as indicated by the treating physician/psychiatrist) - Depressive disorder (as assessed by the treating psychiatrist) - Dutch as first language
Exclusion criteria
Exclusion criteria: - Currently using rivastigmine, galantamine, donezepil (all cholinesterase inhibitors for mild to moderate Alzheimer*s Disease). - Pregnancy and/or lactation/breast feeding - Suspicion of neurodegenerative disorders (as diagnosed earlier) - Contraindications for ECT (recent myocardinfarct, recent cerebrovasculair accident, recent intracranial surgery, pheochromocytoma and instable angina pectoris) - Contraindications for rivastigmine (bradycardia or atrioventricular (AV) conduction disorders (first degree AV-block excluded)) - Patients who have had an allergic reaction to rivastigmine - Cognitive disorder not explained by the depressive episode - If receiving outpatient ECT treatment, having no person available to apply the rivastigmine/non-active patch
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main outcome is change in cognitive performance in three domains between baseline (max. 1 week before the first ECT session) and end of treatment (max. 1 week after the last ECT session). Since cognition comprises different and (largely) independent domains, three different tests assessing different cognitive domains will be main outcomes: verbal memory and learning, verbal fluency and general cognition. These cognitive domains have been shown to be most affected by ECT in our previous work, and recommended by international consensus. We will use three (sub)tests that yield individual standardized scores (based on comprehensive norm groups). Patients receiving ECT showed a significant decline in cognition on these (sub)tests: 1. Dutch adaptation of the Rey Auditory Verbal Learning Test (D-RAVLT; 15 words test): assessing verbal learning and memory. We use the subtest called *delayed recall* as primary outcome variable for this domain. This subtest counts the number of words a participant can correctly recall from a list of words presented 20 minutes earlier. 2. Verbal fluency (the letter N, A, and categorical fluency): assessing verbal fluency. We use the categorical subtest as primary outcome for this domain. This test counts the number of words a participant can produce in one minute from a certain category (e.g. professions or animals). Furthermore, responses to the letter *N* and *A* will be counted. 3. Montreal Cognitive Assessment: the MoCA yields a score that reflects overall cognitive functioning. Different domains (visual, verbal, memory) are tested. The test will take 10-15 minutes. Efficacy of ECT on depressive symptom severity will be assessed with the Hamilton Depression Rating Scale (HAM-D), as part of standard clinical practice. Regarding the outcome prediction algorithm, the accuracy of the prediction model will be used as primary outcome measure, with specificity for non-response and non-remission (defined based on the HAM | — |
Secondary
| Measure | Time frame |
|---|---|
| Electroencephalograpy (EEG) EEG recordings will be performed with BioSemi hardware (Amsterdam, The Netherlands) using a cap with 64 active electrodes, sample frequency 2048 Hz. Patients will be lying down and instructed to lay still with their eyes closed. Resting state recordings will be obtained during 18 minutes. After the resting state recording, an additional recording of a test battery will be applied. A portable BioSemi recording device will be used in all participating centers to ensure standardization of data acquisition. Patients will start with resting state EEG recordings, followed by a small test battery recording of approximately 30 minutes that consists of a Mismatch negativity paradigm and a Selective attention paradigm. For details see below. Quality of life To broaden the scope of ECT treatment and possible positive effects of rivastigmine add-on, we will assess quality of life of the patients. Quality of life will be assessed using the Euro-QoL-5D-5L: This simple, reliable and widely used tool to assesses the quality of life of patients is included to not only get measures of cognitive functioning and depressive symptomatology but also to assess the intervention more comprehensively. It is administered in about 5 minutes. Disability assessment To assess the global level of disability, and specifically, if ECT and rivastigmine have positive effects on the experiences disability, we will use the WHODAS 2.0: World Health Organization Disability Assessment Schedule (WHODAS 2.0 12 item version). The WHODAS 2.0 12 item version is a short and validated assessment scale that measures the disability of/experienced by patients. The 12-item version takes about 5 minutes to complete. Expectation of response At each visit we will ask the patient to assess their own expectation of the likelihood that they will recover. The same question will be asked to the treating physician. The question will range from -5 (negative effect expecte | — |
Countries
Netherlands
Outcome results
None listed