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    Summary
    EudraCT Number:2019-001518-40
    Sponsor's Protocol Code Number:848040001
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-07-18
    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 number2019-001518-40
    A.3Full title of the trial
    Netherlands study of Optimal, PERsonalized Antidepressant use (OPERA-DISCONTINUATION)
    Nederlandse studie naar Optimaal gePERsonaliseerd Antidepressiva gebruik (OPERA-AFBOUW)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Netherlands study of Optimal, PERsonalized Antidepressant use (OPERA-DISCONTINUATION)
    Nederlandse studie naar Optimaal gePERsonaliseerd Antidepressiva gebruik (OPERA-AFBOUW)
    A.3.2Name or abbreviated title of the trial where available
    OPERA-DISCONTINUATION
    OPERA-AFBOUW
    A.4.1Sponsor's protocol code number848040001
    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 SponsorVU Medical Center
    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 supportThe Netherlands Organisation for Health Research and Development (ZonMw)
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU Medical Center
    B.5.2Functional name of contact pointDepartment of Psychiatry
    B.5.3 Address:
    B.5.3.1Street AddressOldenaller 1
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081HJ
    B.5.3.4CountryNetherlands
    B.5.6E-mailopera@vumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Sertraline
    D.2.1.1.2Name of the Marketing Authorisation holdernot fixed in protocol
    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 nameSertraline
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    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 Citalopram
    D.2.1.1.2Name of the Marketing Authorisation holdernot fixed in protocol
    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 nameCitalopram
    D.3.2Product code n/a
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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 placeboTablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Depression
    Depressie
    E.1.1.1Medical condition in easily understood language
    Depression
    Depressie
    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
    To examine in depressed patients who reach a 6-month stable depression remission during optimal AD treatment: 1) whether discontinuation is possible; 2) when discontinuation is possible; and 3) in whom discontinuation is possible.
    Bij depressieve patiënten die gedurende optimale behandeling met antidepressiva een 6 maanden stabiele depressie remissie hebben bereikt, onderzoeken 1) of afbouw van antidepressiva mogelijk is, 2) wanneer afbouw mogelijk is, en 3) bij wie afbouw mogelijk is.
    E.2.2Secondary objectives of the trial
    To conduct a cost-effectiveness analysis
    Uitvoeren van een kosteneffectiviteitsanalyse
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Having a stable depression remission as evidenced by reporting an IDS score ≤21 (i.e. no moderate or severe depressive symptoms) during two consecutive bimonthly assessments and a confirmed absence of a DSM-5 diagnosis of MDD during 6 months, as observed in the OPERA-MONITOR study.
    • Use of sertraline (50, 100, 150 or 200 mg/day) or citalopram (10, 20, 30 or 40 mg/day).
    • Willing to be randomized and provide written informed consent.
    • Aanwezigheid van een stabiele remissie van depressie, gedefinieerd als twee opeenvolgende IDS scores ≤21 (d.w.z. geen matige of ernstige depressieve symptomen) gedurende 2-maandelijkse metingen én afwezigheid van een depressieve stoornis (MDD) volgens DSM-5 criteria gedurende 6 maanden, zoals geobserveerde in de OPERA-Monitor studie.
    • Gebruik van sertraline (50, 100, 150 of 200 mg/per dag) of citalopram (10, 20, 30 of 40 mg/per dag).
    • Bereid om gerandomiseerd te worden en schriftelijk geïnformeerde toestemming te geven. Patiënten die niet gerandomiseerd willen worden, worden uitgenodigd voor deelname in een externe referentiegroep (N=200 van de 600).
    E.4Principal exclusion criteria
    • Earlier inpatient admission for depression.
    • History of >3 prior episodes for which treatment was started.
    • Overall treatment period with antidepressant for the last depressive episode did last more than 18 months (chronic patients are excluded: in this difficult-to-treat group continuation of antidepressants is recommended as a-priori relapse risk is known to be high).
    • Presence of other clinically overt primary psychiatric conditions that warrant different medical attention (earlier confirmed psychosis, schizophrenia or bipolar depression for which medical care has been provided, or alcohol or drug addiction which is currently treated).
    • Insufficient mastery of Dutch language.
    • Eerdere intramurale opname voor depressie.
    • >3 eerdere depressieve episodes waarvoor behandeling is gestart.
    • Totale behandelperiode met antidepressiva voor de laatste depressieve episode duurde langer dan 18 maanden (chronische patiënten worden geexcludeerd: in deze moeilijk te behandelen groep is continuering van antidepressiva aanbevolen omdat het a-priori risico op terugval hoog is).
    • Aanwezigheid van andere primaire psychiatrische aandoening die een andere medisch beleid vereist (eerder vastgestelde psychose of schizofrenie of bipolaire depressie waarvoor medische zorg is ontvangen, alcohol- of drugsverslaving waarvoor momenteel behandeld wordt)
    • Onvoldoende beheersing van de Nederlandse taal.
    E.5 End points
    E.5.1Primary end point(s)
    Primary outcome involves sustained remission time measured as time of follow-up without severe depressive symptoms, inpatient admission for depression and suicide (attempt). Severe depressive symptoms are defined as having an IDS score>25 (moderately/severely depressed) and meeting DSM-5 criteria for MDD for 2 weeks according the psychiatric MINI interview. Suicide attempt is assessed using suicide IDS and MINI items followed up with the suicide behaviour question of the Columbia Suicide Severity Rating Scale (C-SSRS) Screen Version) and should be confirmed by two OPERA-researchers.
    Duur van consistente remissie (tijd zonder depressieve episode, intramurale opname voor depressie en suïcide(poging)).
    Ernstige depressieve symptomen zijn gedefinieerd als een IDS score>25 en voldoen aan de DSM-5 criteria voor een depressieve stoornis (MDD) gedurende 2 weken volgens het psychiatrische MINI interview. Suïcidepoging wordt vastgesteld met behulp van het suïcide items uit de IDS en MINI, gevolgd door de vraag over suïcide gedrag uit de Columbia Suicide Severity Rating Scale (C-SSRS) Screen Versie en bevestiging van twee OPERA-onderzoekers.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At 7, 14, 21, 28, 35, 42, 49, 56, 80 and 104 weeks after baseline assessment.
    Op 7, 14, 21, 28, 35, 42, 49, 56, 80 en 104 weken na baselinemeting.
    E.5.2Secondary end point(s)
    Quality of life, functioning, severity of psychiatric and somatic symptoms (e.g. side effects, withdrawal symptoms).
    Kwaliteit van leven, functioneren, ernst van psychische en somatische symptomen (bijwerkingen, onttrekkingsverschijnselen).
    E.5.2.1Timepoint(s) of evaluation of this end point
    At 7, 14, 21, 28, 35, 42, 49, 56, 80 and 104 weeks after baseline assessment (differs per outcome).
    Op 7, 14, 21, 28, 35, 42, 49, 56, 80 en 104 weken na baselinemeting (wisselt per uitkomst).
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    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 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 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 concerned5
    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
    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 months6
    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: 320
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 80
    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 No
    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 No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state400
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 400
    F.4.2.2In the whole clinical trial 400
    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)
    N/a. Usual care
    N.v.t. Gebruikelijke zorg
    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 Decision2019-07-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-31
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2022-08-12
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