2024-518047-37-01CompletedPhase 4
Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine
PRECISER; Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine
Source: EU CTIS (euclinicaltrials.eu) · Last updated 16 Dec 2024
Brief summary (registry, in English)
The aim of our study is two folded: first, we aim to improve cognition after ECT, improving its acceptability and tolerability and hence increase its application. If ECT would be used for the calculated 26% of patients who have chronic severe depression, morbidity and mortality of this disorder would decrease steeply. Second, we aim to develop a prediction method based on clinical and EEG characteristics, to accurately predict who will respond to ECT. If it is possible to accurately predict ECT response (and non-response), it could be prevented that patients with a low chance of recovery receives ECT without response but with the associated risks.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 2 Dec 2024
- Start date
- 30 Sept 2021
- Lead sponsor
- Universitair Medisch Centrum Groningen
- Diseases
- Depression
- EU CT number
- 2024-518047-37-01
- EudraCT number
- 2020-005633-33
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 100
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently using rivastigmine, galantamine, donezepil (all cholinesterase inhibitors for mild to moderate Alzheimer’s Disease).
Other illness
- 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
Other
- Pregnancy and/or lactation/breast feeding
Who the study is looking for
- 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)
- Dutch as first language
Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Universitair Medisch Centrum Groningen | Groningen | Netherlands | Completed |
| Tergooiziekenhuizen | Hilversum | Netherlands | Completed |
| Sint Antonius Ziekenhuis Stichting | Nieuwegein | Netherlands | Completed |
| Universitair Medisch Centrum Utrecht | Utrecht | Netherlands | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.