Using EEG and Rivastigmine to Improve ECT Outcomes for Depression
Prediction of ECT Treatment Response and Reduction of Cognitive Side-effects Using EEG and Rivastigmine
This study is testing if a medication called rivastigmine can help reduce memory problems in people with severe depression who are receiving electroconvulsive therapy (ECT).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05768126 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effects of rivastigmine on cognitive side effects in patients undergoing electroconvulsive therapy (ECT) for severe depression. The study will utilize electroencephalography (EEG) to predict treatment outcomes and assess cognitive function through various tests and questionnaires. Participants will be randomly assigned to receive either rivastigmine or a placebo while undergoing ECT, allowing researchers to compare the cognitive side effects experienced by both groups. The ultimate goal is to enhance the efficacy of ECT and improve the quality of life for patients suffering from severe depressive disorders.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with a clinical indication for ECT due to unipolar or bipolar depression.
Not a fit: Patients who have received ECT within the last six months or those with contraindications for ECT or rivastigmine will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to reduced cognitive side effects from ECT, making it a more viable treatment option for patients with severe depression.
How similar studies have performed: Previous studies have indicated that cholinesterase inhibitors may help mitigate cognitive side effects of ECT, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Utrecht
- UMC Utrecht — Utrecht, Netherlands (Recruiting)
Study contacts
- Principal investigator: Iris EC Sommer, PhD, MD — UMC Groningen
- Study coordinator: Jasper O. Nuninga, PhD
- Email: j.o.nuninga@umcg.nl
- Phone: +31(6)39139525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.