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    Summary
    EudraCT Number:2021-006108-34
    Sponsor's Protocol Code Number:10140021910006
    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:2022-08-13
    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 number2021-006108-34
    A.3Full title of the trial
    Trial Examining Methods for Antidepressant Discontinuation
    Methoden om antidepressiva te stoppen vergeleken. De TEMPO-studie
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trial Examining Methods for Antidepressant Discontinuation
    Methoden om antidepressiva te stoppen vergeleken. De TEMPO-studie
    A.3.2Name or abbreviated title of the trial where available
    TEMPO
    TEMPO
    A.4.1Sponsor's protocol code number10140021910006
    A.5.4Other Identifiers
    Name:Netherlands Trial RegisterNumber:NL9867
    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 SponsorAmsterdamUMC (location 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 supportZonMW
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAmsterdam UMC / Radboudumc
    B.5.2Functional name of contact pointhttps://www.radboudumc.nl/onderzoek
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117-8/Reinier Postlaan 4
    B.5.3.2Town/ cityAmsterdam/Nijmegen
    B.5.3.3Post code1081HV/6525GC
    B.5.3.4CountryNetherlands
    B.5.6E-mailtempo.psy@radboudumc.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 No
    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 nameParoxetine
    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 No
    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 nameVenlafaxine ER
    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
    D.8 Placebo: 2
    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
    Major Depressive Disorder
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025464
    E.1.2Term Major depressive disorder, single episode in full remission
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level LLT
    E.1.2Classification code 10025455
    E.1.2Term Major depressive disorder, recurrent episode, in full remission
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025465
    E.1.2Term Major depressive disorder, single episode, in partial or unspecified remission
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025456
    E.1.2Term Major depressive disorder, recurrent episode, in partial or unspecified remission
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    TEMPO will directly compare i) conventional dose reduction versus ii) gradual tapering in patients with remitted major depressive disorder (MDD) who use either the commonly used antidepressants paroxetine (PAR) or venlafaxine (VLX) to evaluate the number of patients that can successfully discontinue PAR or VLX based on either discontinuation symptoms or relapse of MDD.
    TEMPO zal i) conventionele dosisverlaging direct vergelijken met ii) geleidelijk afbouwen bij patiënten die in remissie zijn van een depressie, die of het antidepressivum paroxetine (PAR) of venlafaxine (VLX) gebruiken. We gaan evalueren hoeveel patiënten met succes kan stoppen met PAR of VLX op basis van ofwel ontwenningsverschijnselen of terugval in de depressieve stoornis.
    E.2.2Secondary objectives of the trial
    We will additionally evaluate i) long-term effects, including relapse/recurrence of an MDD-episode during 38 weeks of follow-up after discontinuation; ii) identify predictors for who is at increased risk for experiencing such a recurrence; iii) investigate cost-effectiveness of the two discontinuation strategies. If patients fail to discontinue their antidepressants during the double-blind phase, a secondary open label follow up is offered to those wanting to continue their attempt to discontinue and participate in a personalized part of the protocol.
    We zullen daarnaast i) lange termijn effecten evalueren, waaronder terugval/recidivering van een depressieve episode gedurende 38 weken follow-up na stopzetting; ii) voorspellers proberen te identificeren voor wie een verhoogd risico loopt om een dergelijk recidief te ervaren; iii) de kosteneffectiviteit van de twee afbouwstrategieën onderzoeken. Als patiënten tijdens de dubbelblinde fase niet kunnen stoppen met hun antidepressiva, wordt een secundaire open-label follow-up aangeboden aan degenen die willen doorgaan met hun poging om te stoppen. Er wordt dan d.m.v. een gepersonaliseerd deel van het protocol alsnog geprobeerd de antidepressiva af te bouwen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    To be eligible to participate in this study, a subject must meet all of the following criteria:
    • Age 18-75 years
    • Stable 6-month remission of MDD
    • Confirmed >6 months use of PAR (20-50mg) or VLX (75-375mg)
    • Previous MDD episode and current remission confirmed with semi-structured psychiatric interview (MINI).
    • Willing and able to provide informed consent and follow the procedures necessary to participate in the study
    Om in aanmerking te komen voor deelname aan dit onderzoek, moet een proefpersoon aan alle volgende criteria voldoen:
    • Leeftijd 18-75 jaar
    • Stabiele 6 maanden durende remissie van MDD
    • Bevestigd >6 maanden gebruik van PAR (20-50 mg) of VLX (75-375 mg)
    • Vorige MDD-episode en huidige remissie bevestigd met semi-gestructureerd psychiatrisch interview (MINI).
    • Bereid en in staat om geïnformeerde toestemming te geven en de procedures te volgen die nodig zijn om deel te nemen aan het onderzoek
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    • Psychotic/bipolar disorder
    • Severe drug/alcohol addiction that warrants clinical attention
    • Insufficient mastery of Dutch language.
    Een potentiële proefpersoon die aan een van de volgende criteria voldoet, wordt uitgesloten van deelname aan dit onderzoek:
    • Psychotische/bipolaire stoornis
    • Ernstige drugs-/alcoholverslaving die klinische aandacht vereist
    • Onvoldoende beheersing van de Nederlandse taal.
    E.5 End points
    E.5.1Primary end point(s)
    Rate of failure to successfully discontinue antidepressant: defined as significant deviation from discontinuation antidepressant protocol (e.g. switching to rescue medication (≥5 days in total), stopping with discontinuation medication) or significant withdrawal symptoms (increase in modified 15-item DESS from baseline >4 for at least two consecutive assessments)
    Percentage patienten dat niet succesvol kan stoppen met antidepressiva: gedefinieerd als significante afwijking van het antidepressivum afbouwprotocol (bijv. Overschakelen naar noodmedicatie (≥5 dagen in totaal), stoppen met geblindeerde afbouwmedicatie) of significante ontwenningsverschijnselen (toename van gemodificeerde 15-item DESS vanaf baseline > 4 voor minimaal twee opeenvolgende beoordelingen)
    E.5.1.1Timepoint(s) of evaluation of this end point
    End of phase II (contrasted, blinded discontinuation phase) of the trial
    Einde van Fase II (de geblindeerde, gecontrasteerde fase) van het onderzoek.
    E.5.2Secondary end point(s)
    - Withdrawal symptom severity over time relative to baseline (before discontinuation, modified 15-item DESS-score)
    - Depressive symptoms over time (IDS-SR)
    - Relapse/recurrence rate (MDD diagnosis on MINI interview) and time to event during follow-up
    - Daily functioning and Quality of life (EQ-5D-5L)
    - Attitudes towards and perceived difficulty of discontinuation (patient reported)
    - Cost-effectiveness and productivity losses (TiC-P)
    - Ernst van ontwenningsverschijnselen in de loop van de tijd ten opzichte van baseline (vóór stoppoging, gemodificeerde DESS-score van 15 items)
    - Depressieve symptomen gedurende het onderzoek (IDS-SR)
    - Terugval/recidiefpercentage (MDD-diagnose op MINI-interview) en tijd tot terugval/recidief tijdens follow-up
    - Dagelijks functioneren en kwaliteit van leven (EQ-5D-5L)
    - Houding ten opzichte van en waargenomen moeilijkheid om te stoppen (gerapporteerd door patiënt)
    - Kosteneffectiviteit en productiviteitsverliezen (TiC-P)
    E.5.2.1Timepoint(s) of evaluation of this end point
    End of phase II (contrasted, blinded discontinuation phase) of the trial
    End of follow-up phase III (38 weeks after successful discontinuation)
    Einde van Fase II (de geblindeerde, gecontrasteerde fase) van het onderzoek.
    Eindevan follow-up Fase III (38 weken na het succesvol afgebouwd zijn)
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    How can we best disocontinue antidepressants if patients are in remission and decide to stop their antidepressants
    Hoe kunnen we het beste stoppen met antidepressiva als patiënten in remissie zijn en besluiten te willen stoppen met hun antidepressiva?
    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 Yes
    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) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    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 concerned2
    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 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
    Last visit of the last subject
    Laatste visite van de laatste deelnemer
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 state200
    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)
    If patients have successfully discontinued their antidepressants, after follow-up in Phase III (38 weeks) no additional treatment is offered.
    If patients fail to discontinue their antidepressants during the double-blind phase, a secondary open label follow up is offered to those wanting to continue their attempt to discontinue and participate in this personalized part of the protocol (phase IV).
    Als patiënten succesvol zijn gestopt met hun antidepressiva, wordt na follow-up in fase III (38 weken) geen aanvullende behandeling meer aangeboden.
    Als patiënten tijdens de dubbelblinde fase niet stoppen met hun antidepressiva, wordt een secundaire open-label follow-up aangeboden aan degenen die hun poging om te stoppen willen voortzetten. Dat kan door deel te nemen aan het gepersonaliseerde deel van het protocol (fase IV).
    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 Decision2022-09-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-09
    P. End of Trial
    P.End of Trial StatusOngoing
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