Overview
Sponsor-declared trial summary
Depression
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. …
Key facts
- Sponsor
- Universitair Medisch Centrum Groningen
- Participant type
- Patients
- Age range
- 18-64 years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03]
- Trial duration
- completed 3 Jun 2025
- Decision date (initial)
- 2024-12-16
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2024-518047-37-01
- EudraCT number
- 2020-005633-33
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Prophylaxis, Efficacy
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 objectives 7
- 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.
Conditions and MedDRA coding
Depression
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2024-518047-37-00 | PRECISER; Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine | Universitair Medisch Centrum Groningen |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- 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
Exclusion criteria 7
- 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
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- 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 endpoints 7
- 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
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB10345MIG · Substance
- Active substance
- Rivastigmine
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 4.6 mg milligram(s)
- Max total dose
- 4.6 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Introduction of a new transdermal patch formulation to provide an additional dosing option for patients with moderate to severe dementia.
SUB10345MIG · Substance
- Active substance
- Rivastigmine
- Pharmaceutical form
- TRANSDERMAL PATCH
- Route of administration
- TRANSDERMAL USE
- Max daily dose
- 9.5 mg milligram(s)
- Max total dose
- 9.5 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- Yes
- Modification description
- Introduction of a new transdermal patch formulation to provide an additional dosing option for patients with moderate to severe dementia.
Placebo 2
Rivastigmin adhesive plaster 9.5 mg placebo containing 0 mg of rivastigmin
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Rivastigmin adhesive plaster 4.6 mg placebo containing 0 mg of rivastigmin
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Universitair Medisch Centrum Groningen
- Sponsor organisation
- Universitair Medisch Centrum Groningen
- Address
- Hanzeplein 1
- City
- Groningen
- Postcode
- 9713 GZ
- Country
- Netherlands
Scientific contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Jasper Nuninga
Public contact point
- Organisation
- Universitair Medisch Centrum Groningen
- Contact name
- Jasper Nuninga
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ended | 100 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2024-518047-37-01 | 3.3 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 4.5 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Rivastigmin | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-02 | Netherlands | Acceptable 2024-12-16
|
2024-12-16 |