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    Summary
    EudraCT Number:2014-003385-24
    Sponsor's Protocol Code Number:2815
    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:2015-03-09
    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 number2014-003385-24
    A.3Full title of the trial
    The Recall-study: Rivastigmine for ECT-induced Cognitive Adverse effects in Late Life Depression: a multicenter, randomized, double-blind, placebo-controlled, crossover trial
    De Recall studie: Rivastigmine voor ECT-geinduceerde cognitieve stoornissen bij depressie op late leeftijd: een multicenter dubbel blinde gerandomiseerde placebogecontroleerde crossover studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Rivastigmine treatment for electroconvulsive therapy- induced confusion in elderly depressed patients
    Rivastgmine voor de behandeling van verwardheid gedurende electroconvulsieve therapie bij depressieve ouderen
    A.3.2Name or abbreviated title of the trial where available
    Rivastigmine treatment for ECT-induced cognitive adverse effects in depressed elderly
    Rivastigminebehandeling voor ECT- geinduceerde cognitieve stoornissen bij depressieve ouderen
    A.4.1Sponsor's protocol code number2815
    A.5.4Other Identifiers
    Name:Nederlands Trial Register Number:volgt
    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 SponsorGGZ inGeest, parner VUmc
    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 supportGGZ inGeest, partner van VUmc
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGGZ inGeest, partner van VUmc
    B.5.2Functional name of contact pointopname ouderen
    B.5.3 Address:
    B.5.3.1Street AddressAmstelveenseweg 589
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1181 JC
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031207885000
    B.5.6E-maild.rhebergen@ggzingeest.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 holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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.3.11 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
    Interictal delirium during electric convulsive therapy- course
    Interictaal delier tijdens electro convulsieve therapie
    E.1.1.1Medical condition in easily understood language
    Delirium during and due to electro convulsive therapy-course (ECT). Delrium is a (sub)acute and severe confusional state and a reaction of the brain to in this study ECT
    Delier tijdens en veroorzaakt door electroconvulsieve therapie (ECT). Een delier is een (sub)acute en ernstige verwardheid en een ractie van het brein op, in deze studie, ECT
    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 this study is twofold. The main aim of this study is twofold. We aim to (1) investigate whether rivastigmine can be used as a novel treatment to reduce ECT-induced interictal delirium and (2) to gain further insight in the different types of cognitive disturbances induced by ECT and its correlates by creating a large cohort of ECT patients.
    Het doel van het onderzoek is tweeledig:
    Ten eerste 1) willen wij onderzoeken of rivastigmine kan worden toegepast als de behandeling van het interictaal delier en
    ten tweede 2) willen wij meer inzicht verkrijgen in de verschillende typen van ECT-geinduceerde cognitieve stoornissen door een groot cohort te realiseren van ECT patienten
    E.2.2Secondary objectives of the trial
    To describe
    - influence rivastgmine on several ECT and anaesthetic parameters (sedation, medication use, reorientation time, effects on muscle relaxation, bloodpressure, etc)
    - tolerability of rivastigmine during ECT
    For differentiation into subtypes of confusional states and their determinants:
    - Profiles of confusional states based on scores on reorientation time, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, clock-drawing-test, all assessed during ECT, and their determinants.
    Beschrijven van
    - effect rivastigmine op verschillende ECT en anesthesie parameterts (sedatie, medicatie gebruik, reorientatie tijd, effecten op spierrelaxatie, bloeddruk, ect)
    - Tolerantie rivastigmine gedurende ECT
    Ter onderscheiding verschillende typen ECT geinduceerde cogntieve stoornissen:

    - Profielen schetsen obv scores op reorientatietijd, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, kloktekentest gedurende ECT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient is admited at the in-wards of one of the participating psychiatric hospitals
    - Patients fulfilling the Composite International Diagnostic Interview (CIDI) criteria of a Major Depressive Episode (not necessarily in the context of a Major Depressive Disorder only)
    - Patient is indicated for ECT-treatment.
    - Patient or legal representitive is able to give informed consent
    - Occurence of an interictal delirium is assessed by the Confusion Assessment method (CAM) and/ or 4 pts drop Mini Mental State Examination score (MMSE)
    - patient is opgenomen op de opnameafdeling van de een van de deelnemende psychiatrische ziekenhuizen
    - Patient voldoet aan Composite International Diagnostic Interview (CIDI) criteria van een ernstige depressieve episode, niet noodzakelijkerwijs in de context van alleen een ernstige depressieve stoornis
    - Patient of wettelijk vertegenwoordiger is in staat tot geven informed consent
    - Optreden van interictaal delier volgens de Confusion Assessment method (CAM) en/of 4 punten daling Mini Mental State Examination score (MMSE)
    E.4Principal exclusion criteria
    - Patients not meeting the inclusion criteria
    - Patient has a comorbid medical condition that is a contraindication for ECT according to the prevailing Dutch ECT-guidelines
    - Current use of rivastigmine or an other cholinesterase inhibitor
    - Known intolerance of rivastigmine or an other cholinesterase inhibitor
    - Bradycardia or AV conduction disorder at baseline ECG (first degree AV block exluded)
    - switch from right unilateral electrodeplacement (RUL) to bilateral electrodeplacement (BL) during trial
    - Patient voldoet niet aan inclusie criteria
    - Aanweizigheid van comorbiditeit die geldt als contra indicatie voor ECT volgends de huidige Nederlandse ECT richtlijn
    - Gelijktijdig gebruik van rivastigmine of een andere cholinesteraseremmer
    - Bekende intolerantie voor rivastigmine of een andere cholinesteraseremmer.
    - Bradycardie danwel AV geleidingsstoornis op baseline ECG (excl 1e graads AV blok)
    - switch van uni naar bilaterale electrodeplaatsing tijdens ECT
    E.5 End points
    E.5.1Primary end point(s)
    1. Scores on Delirium Rating Scale (DRS-98), assessed after two ECT sessions with rivastigmine, compared with DRS-98 outcomes assessed after two ECT sessions without rivastigmine .
    2. Scores on cognitive functioning tests (MMSE, fluency, clock-drawing-test), assessed after two ECT sessions with rivastigmine, compared with outcomes assessed after two ECT sessions without rivastigmine.
    NB baseline scores: mainained 48-24h before first ECT session within trial.
    Primaire uitkomsten
    1. Score op Delirium Rating Scale (DRS 98) bepaald na 2x ECT met rivastgmine, vergeleken met DRS score na 2X ECT zonder rivastigmine en baseline scores
    2. Scores op multipele cognitieve testen (MMSE, fluency en kloktekentest) bepaald na 2x ECT met rivastgmine, vergeleken met DRS score na 2X ECT zonder rivastigmine en baseline scores
    NB baseline sores: verkregen 48-24uur voor de eerste ECT sessie in de trial
    E.5.1.1Timepoint(s) of evaluation of this end point
    Final scores will be obtained 1 day after the final ECT session in the trial
    Laaste scores worden verkregen 1 dag na de laatste ECT sessie binnen de trial
    E.5.2Secondary end point(s)
    3.Impact of rivastigmine on several ECT characteristics (bloodpressure, heart rate, seizure length, post ictal supression index, seizure threshold, time of – anesthesia induced - muscle relaxation, type of anesthetics and dosage) measured during ECT.
    4.Adverse/ side effects of rivastigmine.

    For differentiation into subtypes of confusional states and their determinants:
    5. Profiles of confusional states based on scores on reorientation time, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, clock-drawing-test, all assessed during ECT, and their determinants.
    3. Effect van rivastigmine op verscheidene ECT paramaters (bloeddruk, hartslag, insult duur, post ictale suppressie index, prikkeldrempel, spierrelaxatie, type anesthetica en dosis) gedurende ECT
    4. Bijwerkingen

    Ter onderscheiding verschillende typen ECT geinduceerde cogntieve stoornissen:

    - Profielen schtesen obv scores op reorientatietijd, Richmond Agitation Sedation Scale (RASS), Confusion Assessment Methods (CAM)/Delirium Rating Scale (DRS-98), MMSE, fluency, kloktekentest gedurende ECT
    E.5.2.1Timepoint(s) of evaluation of this end point
    Final scores for secondary endpoint will be obtained 1 day maximum after the final ECT session in the trial

    Alle secundaire eindpunten zullen maximaal 1 dag na de laatste ECT sessie binnen de trial worden verkregen.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    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 Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA4
    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 No
    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
    End of the trial is defined as the date of data disclosure, after the last data collection of the last patient; namely 1 day after final ECT session within the trial.
    Einde studie is gedefinieerd als moment waarop data base gesloten wordt, dit is op moment wanneer data van de laatst patient verzameld zijn, namelijk 1 dag na de laaste ECT sessie in de trial
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 38
    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 No
    F.3.3.2Women of child-bearing potential using contraception No
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    We include severely depressed elderly patients. If a patient is not capable of giving informed consent, we will ask the legal representative.

    Wij includeren ernstig depressieve oudere patienten. Wanneer de patient niet in staat is tot informed consent, zal dit worden gevraagd aan de wettelijk vertegenwoordiger.

    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 38
    F.4.2.2In the whole clinical trial 38
    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)
    None, only regular care
    None, alleen gebruikelijke behandeling
    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 Decision2015-03-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-09-28
    P. End of Trial
    P.End of Trial StatusOngoing
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