Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine

Phase 1

• Conditions: A depressive disorder; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2020-005633-33-NL
• Lead Sponsor: niversity Medical Center Groningen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-03-10
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

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)
-Dutch as first language
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion Criteria

- Currently receiving, or having received ECT 6 months prior to the start of the treatment/study.
- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified