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    The EU Clinical Trials Register currently displays   36118   clinical trials with a EudraCT protocol, of which   5940   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2006-004457-20
    Sponsor's Protocol Code Number:P051071
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2008-03-25
    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 ConcernedFrance - ANSM
    A.2EudraCT number2006-004457-20
    A.3Full title of the trial
    Evaluation de l'action neuroréparatrice fonctionnelle et morphologique du traitement antidepresseur au cours de la rémission clinique dans la dépression recurrente.
    A.3.2Name or abbreviated title of the trial where available
    RESILIENCE
    A.4.1Sponsor's protocol code numberP051071
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    B.1.3.4CountryFrance
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 Stablon
    D.2.1.1.2Name of the Marketing Authorisation holderServier
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameStablon
    D.3.2Product code Stablon
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNTianeptine
    D.3.9.1CAS number 66981-73-5
    D.3.9.3Other descriptive nameStablon
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number12,5 mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 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 Effexor
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth-Lederlé
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameEffexor
    D.3.2Product code Effexor
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNVenlafaxine
    D.3.9.1CAS number 99300-78-4
    D.3.9.3Other descriptive nameEffexor
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50 mg
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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: 3
    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 Norset
    D.2.1.1.2Name of the Marketing Authorisation holderOrganon
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameNorset
    D.3.2Product code Norset
    D.3.4Pharmaceutical form Buccal tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNMirtazapine
    D.3.9.1CAS number 61337-67-5
    D.3.9.3Other descriptive nameNorset
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 placeboBuccal tablet
    D.8.4Route of administration of the placeboBuccal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Dépression récurrente
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 8.1
    E.1.2Level PT
    E.1.2Classification code 10025454
    E.1.2Term Dépression récurrente
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluer l'impact des recurrences de la dépression au niveau des structures Hyppocampiques et des fonctions cognitives dans le trouble Dépressif majeur Récurrent (TDMR)(DSM-IV) en phase aïgu, par rapport aux sujets témoins(ST) et aux patients présentant leur premier épisode dépressif majeur (PED)
    E.2.2Secondary objectives of the trial
    1- Evaluer l'impact des recurrences de la dépression sur les fonctions cognitives dans le trouble dépressif majeur récurent(DMR)(DSM-IV), d'évaluer le lien entre l'atrophie de l'hyppocampe et la resistance aux traitements antidépresseurs, d'évaluer par l'analyse IRM: le potentiel neuroréparateur d'un traitement antidépresseur de consolidation, le potentiel neuroréparateur de la tianeptine.
    - 1) d'évaluer l'impact des récurrences de la dépression sur les fonctions cognitives dans le trouble dépressif majeur récurrent
    2) d'évaluer le lien entre l'atrophie de l'hyppocampe etl a résistance au traitement anti-dépresseur
    3) d'évaluer par l'analyse d'IRM
    - le potentiel neuroréparateur d'un traitement anti-dépresseur de consolidation
    - le potentiel neuroréparateur de le tianeptine
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Critère d'inclusion des patients
    - patients hospitalisés, n'ayant pas répondu en ambulatoire, au traitement antidépresseur
    - hommes et femmes âgées de 18 à 55 ans
    - patient répondant aux critères DSM-IV d'un trouble dépressif majeur récurrent, Récurrent soit d'un Trouble dépressif majeur, Episode isolée
    - score à la MADRS supérieur ou égal à 20
    - langue maternelle : français
    - consentement éclairé et écrit du patient
    - absence de comorbidité sur l'axe I et sur l'axe II du DMS IV (ex: abus d'alcool et /ou de substance tosique, état de stress post-traumatique, etc.)
    - absence d'affection somatiques susceptibles d'affecter les capacités cognitives et les structurtes cérébrales (infection par VIH, SEP, Lupus, maladie de parkinson, épilepsie, démences, endocrtinopathie, etc...)

    - Critères d'inclusion des sujets témoins
    - sujets indemnes de troubles mentaux sur l'axe 1 et 2 du DSM-IV après évaluation par l'entretien clinique (critère de la DSP) et par l'entretien structuré ( le MINI)
    - consentement éclairé et écrit du sujet
    - âge compris entre 18 et 55 ans
    E.4Principal exclusion criteria
    Patients
    - score supérieur ou égal à 2 à l'item "idées suicidaires" de la MADRS
    - contre-indication à la réalisation d'une IRM (...), une évaluation de la faisabilité de l'IRM sera systématiquement effectuée avant l'examen
    - malades hospitalisés sous contrainte selon les termes de la loi du 27 juin 1990 (hospitalisation sur le demande d'un tiers ou hospitalisation d'office)
    - antécédents ou indication actuelle de traitement par électroconvulsivothérapie (ECT) qui est susceptible d'induire des troubles mnésiques pour la deuxième partie de l'étude;
    - antécédent de traitement par thymorégulateur (sels du lithium, vaproate, tegrétol) dans les 5 ans ayant précédé l'inclusion
    - potentialisation récente par le extraits thyroïens (Cynomel, DCI? liothyronine sodique; cp 25microg) dans les 6 mois qui ont précédé l'inclusion
    - grossesse
    - contre indication à l'utilisation de IRSNA + NASSA
    - non affiliation à un régime de sécurité sociale (bénéficiéire ou ayant droit).

    Témoins
    - contre indication à la réalisation de l'examen IRM
    - affections médicales susceptibles d'affecter les capacités cognitives et les structurtes cérébrales (infection par VIH, SEP, Lupus, maladie de parkinson, épilepsie, démences, etc...)
    - non affiliation à un régime de sécurité sociale (bénéficiaire ou ayant droit)
    - grossesse

    E.5 End points
    E.5.1Primary end point(s)
    Principal: volume de l'hippocampe mesuré par l'IRM (technique VBM), qui sera comparé à l'inclusion entre deux groupes de patients: patient TDMR et le groupe composé de ST et PED. Variables mesurées et méthodologie: les variables d'IRM caractérisant la densité en substance grise et le volume de l'hippocampe.

    Secondaires
    -variables cliniques et psychopathologiques: scores aux échelles (MADRS, HAD, EGF, CGI).
    La réponse au traitement anti-dépresseur au cours d'un épisode dépressif majeur a été définie par une baisse > ou = à 50% du score à l'échelle MADRS.
    Les indices cliniques ont été évalués par le MINI et l'entretien clinique ainsi que par le recueil des informations auprès des médecins traitants et l'étude du dossier médical , ces variables étaient l'âge, le sexe, le nombre d'épisodes dépressifs, l'âge des début des troubles, le nombre d'hospitalisation, la durée de l'épisode actue, la durée de la maladie, les caractéristique symptomatiques de l'épisode dépressif actuel.

    -variables cognitives: scores de tests (questionnaires)
    Chaque épreuve cognitive a donné lieu à un ensemble de sous-scores qui ont été ajustés selon les normes d chaque tests tenant compte de l'âge des sujets et du niveau socio-éducatif.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Impact anatomo-clinique des récurrences dépressives.
    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 Yes
    E.7.1.3.1Other trial type description
    Impact du traitement au niveau de l'hippocampe
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 Information not present in EudraCT
    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
    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 months4
    E.8.9.1In the Member State concerned days0
    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.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 2008-03-25. 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 Yes
    F.3.3.7.1Details of other specific vulnerable populations
    Adultes (18-55 ans)
    F.4 Planned number of subjects to be included
    F.4.1In the member state88
    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 Decision2008-07-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-18
    P. End of Trial
    P.End of Trial StatusOngoing
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