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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518047-37-01
Acronym
202000842
Enrollment
100
Registered
2024-12-16
Start date
Unknown
Completion date
2025-06-03
Last updated
2024-12-16

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

Conditions

Depression

Brief summary

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

Detailed description

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

Interventions

DRUGRIVASTIGMINE
DRUGRivastigmin adhesive plaster 9.5 mg placebo containing 0 mg of rivastigmin
DRUGRivastigmin adhesive plaster 4.6 mg placebo containing 0 mg of rivastigmin

Sponsors

Universitair Medisch Centrum Groningen
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
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

Secondary

MeasureTime frame
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

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026