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    Summary
    EudraCT Number:2020-005633-33
    Sponsor's Protocol Code Number:202000842
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-10
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2020-005633-33
    A.3Full title of the trial
    Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prediction of ECT treatment response and reduction of Cognitive Side-effects using EEG and Rivastigmine
    A.4.1Sponsor's protocol code number202000842
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorUniversity Medical Center Groningen
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportNetherlands Organization for Scientific Research
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Medical Center Groningen
    B.5.2Functional name of contact pointj.o.nuninga@umcg.nl
    B.5.3 Address:
    B.5.3.1Street AddressAntoni Deusinglaan 1
    B.5.3.2Town/ cityGroningen
    B.5.3.3Post code9713 GZ
    B.5.3.4CountryNetherlands
    B.5.6E-mailj.o.nuninga@umcg.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Rivastigmine
    D.2.1.1.2Name of the Marketing Authorisation holderSandoz B.V.
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameRivastigmine
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNRIVASTIGMINE
    D.3.9.1CAS number 123441-03-2
    D.3.9.4EV Substance CodeSUB10345MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number4.6 to 9.5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTransdermal patch
    D.8.4Route of administration of the placeboTransdermal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    A depressive disorder
    E.1.1.1Medical condition in easily understood language
    Depression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    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.
    E.2.2Secondary objectives of the trial
    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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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
    E.5.1.1Timepoint(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
    E.5.2Secondary 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
    E.5.2.1Timepoint(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
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Non-active patch
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2021-03-10. Yes
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    One additional consultation visit, upon request from the patients
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2021-03-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-02
    P. End of Trial
    P.End of Trial StatusOngoing
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