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

Recruiting

Conditions: Depression

Registration Number: NL-OMON27806

Lead Sponsor: MC Groningen (investigator initiated)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 100

Inclusion Criteria

Age over 18 years
- Clinical indication for ECT (as indicated by the treating physician/psychiatrist)
- A depressive episode (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, donezepil (or another cholinesterase inhibitor).
- 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

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The first objective is to investigate whether rivastigmine could protect against the cognitive (and memory) side effects of ECT. Cognitive (and memory) side effects will be quantified using: the Dutch Rey Auditory Verbal learning Test (D-RAVLT, 15 woorden test”), the word fluency test, the Montreal Cognitive Assessment (MoCA) and the Columbia Autobiographical Memory Interview [CUAMI (McElhiney, Moody, & Sackeim, 2001; Mulder, Dekker, & Dekker, 2006; Nasreddine et al., 2005; Van der Elst et al., 2005)].

Secondary Outcome Measures

Name	Time	Method
The second objective is to develop prediction markers of treatment outcome concerning depressive symptoms and cognitive functioning using EEG. Treatment outcome will be assessed using the Hamilton Depression Rating Scale (Hamilton, 1960). Cognition will be assessed as outlined above. In addition, train of four (TOF) measures, and WHODAS, EURO-QoL, SAMI, CFQ, expectation of response, free speech (PRAAT), and blood samples will be analysed.