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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27806

Enrollment

100

Registered

2021-08-26

Start date

2021-09-29

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Rivastigmine addition to ECT-course

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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)].	—

Measure

Time frame

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)].

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactJasper Nuninga

University Medical Center Groningen

j.o.nuninga@umcg.nl0639139525

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)