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    The EU Clinical Trials Register currently displays   43874   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2012-002817-20
    Sponsor's Protocol Code Number:Trojak-APJ-2012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-09-25
    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 number2012-002817-20
    A.3Full title of the trial
    Etude préliminaire visant à étudier l’effet de la rTMS et des antidépresseurs ISRS sur l’expression leucocytaire des gènes C-FOS et DUSP1 des patients traités pour un état dépressif
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Etude sur l’effet de la stimulation magnétique et des antidépresseurs sur l’expression des gènes C-FOS et DUSP1 des patients traités pour un état dépressif
    A.3.2Name or abbreviated title of the trial where available
    TMSFOS
    A.4.1Sponsor's protocol code numberTrojak-APJ-2012
    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 SponsorCHU Dijon
    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 supportDIRC Est
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHU Dijon
    B.5.2Functional name of contact pointResponsable promotion
    B.5.3 Address:
    B.5.3.1Street Address14 rue Gaffarel
    B.5.3.2Town/ cityDijon
    B.5.3.4CountryFrance
    B.5.4Telephone number33380295618
    B.5.6E-mailmaud.carpentier@chu-dijon.fr
    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 ZOLOFT
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER HOLDING FRANCE
    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.3.4Pharmaceutical form Capsule
    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 SEROPLEX
    D.2.1.1.2Name of the Marketing Authorisation holderLUNDBECK A/S
    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.3.4Pharmaceutical 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    troubles dépressifs majeurs
    E.1.1.1Medical condition in easily understood language
    dépression
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.0
    E.1.2Level LLT
    E.1.2Classification code 10029198
    E.1.2Term Nervous breakdown
    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
    Etudier l’évolution de l’expression leucocytaire de C-FOS et DUSP1 lors de l’administration de 2 thérapeutiques antidépressives (la rTMS et les antidépresseurs de la classe des Inhibiteurs de la Recapture de la Sérotonine-ISRS), et la comparer à l’amélioration clinique des patients souffrant de troubles dépressifs majeurs
    E.2.2Secondary objectives of the trial
    1- Rechercher une corrélation entre le niveau d’expression génétique de C-FOS et DUSP1 (seuils) et l’amélioration clinique des patients souffrant de troubles dépressifs majeurs

    2- Evaluer la valeur prédictive, en tant que facteur de réponse thérapeutique, de l'expression leucocytaire des gènes C-FOS et DUSP1 chez des patients déprimés traités par rTMS ou par un antidépresseur ISRS

    3- Comparer la cinétique de la modification de l’expression génétique de C-FOS et DUSP1 en fonction de la thérapeutique antidépressive utilisée, de la réponse thérapeutique et de la durée d’administration

    4- Recherche de facteurs annexes pouvant moduler l’expression de C-FOS et DUSP1 (âge, sexe, anxiété, tabagisme…).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Patient souffrant d’un épisode dépressif sévère (critères du DSM IV-TR)
    - Troubles dépressifs d’intensité sévère (score à l’échelle de Hamilton-17 items ≥ 20)
    - Echec à au moins un traitement antidépresseur médicamenteux prescrit à posologie efficace
    - Patient ayant donné son consentement écrit
    - Patient âgé de 18-65 ans
    E.4Principal exclusion criteria
    - Personne non affiliée à un régime de sécurité sociale
    - Patients souffrant de troubles bipolaires de type I ou II
    - Patients souffrant de dépression avec caractéristiques psychotiques
    - Patients souffrant de schizophrénie
    - Usage à risque ou nocifs d’alcool et/ou d’une substance psycho-active illicite.
    - Dépendance à l’alcool et/ou à une substance psycho-active illicite.
    - Patient ne pouvant consentir au protocole en raison de leur troubles mentaux ne peuvent être inclus dans l’étude : malade hospitalisé sous contrainte (HO, HDT) ou sous mesure de protection juridique (tutelle, curatelle)
    - Contre-indication à la pratique de la rTMS ; antécédents personnels de crise convulsive, pacemaker, clips neurochirurgicaux, clips carotidiens ou aortiques, valves cardiaques, prothèse auditive, valve de dérivation ventriculaire, sutures avec fils métalliques ou agrafes, corps étrangers dans l’œil, éclats d’obus, autre prothèse ou matériel ferromagnétique céphalique, travail dans les métaux.
    - Contre-indication à la réalisation d’une IRM cérébrale
    - Contre-indication à la prescription d’un ISRS
    - Grossesse ou allaitement en cours : un dosage des béta-HCG sera réalisé avant l’entrée dans le protocole (femme en âge de procréer)
    E.5 End points
    E.5.1Primary end point(s)
    Biologique : Evolution de l’expression leucocytaire des gènes C-FOS et DUSP1 après 2 semaines, 4 semaines et 8 semaines d’un traitement par rTMS ou un antidépresseur ISRS (escitalopram, sertraline)
    E.5.1.1Timepoint(s) of evaluation of this end point
    aprés 2 semaines, 4 semaines et 8 semaines de traitement
    E.5.2Secondary end point(s)
    1. Comparaison du taux moyen de l’expression leucocytaire des gènes C-FOS et DUSP1 à l’inclusion entre les patients déprimés avant traitement et ceux non-déprimés d’une part, les patients déprimés traités par rTMS et ceux par ISRS d’autre part.
    2. Corrélation entre l’évolution de l’expression leucocytaire des gènes C-FOS et DUSP1 avant et après traitement et la réponse clinique au traitement.
    La réponse clinique au traitement sera définie à 8 semaines par une amélioration d’au moins 50% à échelle d’Hamilton
    E.5.2.1Timepoint(s) of evaluation of this end point
    aprés 2 semaines, 4 semaines et 8 semaines de traitement
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stimulation magnétique transcrannienne
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months18
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months18
    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: 40
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 No
    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 2012-09-25. 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 No
    F.4 Planned number of subjects to be included
    F.4.1In the member state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 0
    F.4.2.2In the whole clinical trial 0
    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)
    Adaptation du traitement à l'évolution de la maladie
    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 Decision2013-02-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-01-01
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-06-05
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