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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005633-33-NL

Enrollment

100

Registered

2021-03-10

Start date

2021-06-02

Completion date

Unknown

Last updated

2025-04-14

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

Conditions

A depressive disorder

Interventions

Trade Name: Rivastigmine Product Name: Rivastigmine Pharmaceutical Form: Transdermal patch INN or Proposed INN: RIVASTIGMINE CAS Number: 123441-03-2 Concentration unit: mg milligram(s) Concentration t

Eligibility

Sex/Gender

All

Inclusion 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) - 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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: To investigate quality of life related measures after rivastigmine addition. To investigate whether free speech is predictive of the antidepressant effects. To investigate whether EEG could predict cognitive impairment. To investigate how network related measures change during an ECT course. To investigate how blood and DNA methylation change during ECT. To develop a comprehensive prediction method based on the available parameters. To investigate subjective measures of (anticipation) of response and side effects.;Primary end point(s): - No change in the rivastigmine group on cognitive and memory related measures (compared to an effect in the placebo group): significant interaction term between placebo and rivastigmine AND non-significant comparison on cognition and memory measures in the rivastigmine group between the timepoints (versus significant difference in the placebo group): at p <0.05 - Classification algorithm for ECT response: accurate and statistically significant at p<0.05 - Classification algorithm for side effects: accurate and statistically significant at p<0.05;Timepoint(s) of evaluation of this end point: Baseline versus end-of-treatment and baseline versus follow-up (3 months), and end-of-treament versus follow-up	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: To investigate quality of life related measures after rivastigmine addition. To investigate whether free speech is predictive of the antidepressant effects. To investigate whether EEG could predict cognitive impairment. To investigate how network related measures change during an ECT course. To investigate how blood and DNA methylation change during ECT. To develop a comprehensive prediction method based on the available parameters. To investigate subjective measures of (anticipation) of response and side effects.;Primary end point(s): - No change in the rivastigmine group on cognitive and memory related measures (compared to an effect in the placebo group): significant interaction term between placebo and rivastigmine AND non-significant comparison on cognition and memory measures in the rivastigmine group between the timepoints (versus significant difference in the placebo group): at p <0.05 - Classification algorithm for ECT response: accurate and statistically significant at p<0.05 - Classification algorithm for side effects: accurate and statistically significant at p<0.05;Timepoint(s) of evaluation of this end point: Baseline versus end-of-treatment and baseline versus follow-up (3 months), and end-of-treament versus follow-up

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Secondary

Measure	Time frame
Secondary end point(s): To investigate quality of life related measures after rivastigmine addition: significant for the different measures at p<0.05 To investigate whether free speech is predictive of the antidepressant effects: classification (significant at p<0.05) AND significant (non)linear modelling at p<0.05 To investigate whether EEG could predict cognitive impairment: accurate and statistically significant at p<0.05 To investigate how network related measures change during an ECT course: statistically significant change between timepoints (p<0.05) To investigate how blood and DNA methylation change during ECT (or are predictive): p<0.05 To develop a comprehensive prediction method based on the available parameters: statistically significant change between timepoints (p<0.05) To investigate subjective measures of (anticipation) of response and side effects: p < 0.05;Timepoint(s) of evaluation of this end point: Baseline versus end-of-treatment and baseline versus follow-up (3 months), and end-of-treament versus follow-up And baseline vs timepoint after 1st ECT session timepoint after 1st ECT session vs end-of-treatment and follow-up	—

Measure

Time frame

Secondary end point(s): To investigate quality of life related measures after rivastigmine addition: significant for the different measures at p<0.05 To investigate whether free speech is predictive of the antidepressant effects: classification (significant at p<0.05) AND significant (non)linear modelling at p<0.05 To investigate whether EEG could predict cognitive impairment: accurate and statistically significant at p<0.05 To investigate how network related measures change during an ECT course: statistically significant change between timepoints (p<0.05) To investigate how blood and DNA methylation change during ECT (or are predictive): p<0.05 To develop a comprehensive prediction method based on the available parameters: statistically significant change between timepoints (p<0.05) To investigate subjective measures of (anticipation) of response and side effects: p < 0.05;Timepoint(s) of evaluation of this end point: Baseline versus end-of-treatment and baseline versus follow-up (3 months), and end-of-treament versus follow-up And baseline vs timepoint after 1st ECT session timepoint after 1st ECT session vs end-of-treatment and follow-up

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Countries

Netherlands

Contacts

Public Contactj.o.nuninga@umcg.nl

University Medical Center Groningen

j.o.nuninga@umcg.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026