NCT05768126 Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
| NCT ID | NCT05768126 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | UMC Utrecht |
| Condition | Depressive Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2021-09-29 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2021-09-29 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to test the beneficial effects of rivastigmine administration, and predict the treatment outcome with electroencephalography (EEG), in patients with severe depression treated with electroconvulsive therapy (ECT). The study has two main objectives: * to study whether rivastigmine would ameliorate the side-effect profile of ECT * to develop an outcome prediction model based on resting state EEG for both the response to treatment as well as its side effect Participants will be assessed by: * Cognitive tests * Questionnaires of clinical symptoms * Questionnaires of depressive symptoms * Bloodsample * Resting state and task-based EEG Researchers will compare patients with a depressive disorder treated with ECT receiving rivastigmine to placebo patches to see if rivastigmine reduces cognitive side effects.
Eligibility Criteria
Inclusion Criteria: * Age over 18 years * Clinical indication for ECT (as indicated by the treating physician/psychiatrist) * Uni- or bipolar depression (as assessed by the treating psychiatrist) * Fluent in Dutch Exclusion Criteria: * Currently receiving, or having received ECT 6 months prior to the start of the treatment/study. * Currently using rivastigmine, galantamine, donepezil (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 myocardial infarction, recent cerebrovascular 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
Frequently Asked Questions
Who can join the NCT05768126 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Depressive Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05768126 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05768126 currently recruiting?
Yes, NCT05768126 is actively recruiting participants. Visit ClinicalTrials.gov or contact UMC Utrecht to inquire about joining.
Where is the NCT05768126 trial being conducted?
This trial is being conducted at Utrecht, Netherlands.
Who is sponsoring the NCT05768126 clinical trial?
NCT05768126 is sponsored by UMC Utrecht. The trial plans to enroll 100 participants.