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    Summary
    EudraCT Number:2009-014056-30
    Sponsor's Protocol Code Number:AOI 2009 - Jalenques
    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:2009-08-05
    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 number2009-014056-30
    A.3Full title of the trial
    Reconnaissance des expressons faciales émotionnelles chez les patients présentant un épisode dépressif magnétique transcranienne répétée du cortex préfrontal dorsolatéral droit à basse fréquence et/ou venlafaxine
    A.4.1Sponsor's protocol code numberAOI 2009 - Jalenques
    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 SponsorCHU Clermont-Ferrand
    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 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 pharmaceutical 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 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.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 225
    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 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
    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
    L’objectif principal : montrer la supériorité, chez les patients présentant un EDM résistant à un antidépresseur, de l’association « SMTr – Venlafaxine » dans l’amélioration de la REFE à J4 en comparaison avec des patients recevant « Venlafaxine + placebo de SMTr » « ou SMTr + médicament placebo » et à une population témoin.
    E.2.2Secondary objectives of the trial
    - Montrer qu’une réponse améliorée précoce de la reconnaissance des EFE (à J4, soit après 5 jours de traitement) serait prédictive d’une réponse antidépressive au traitement (quel que soit le bras).
    - Préciser les données sur les activités cognitives de reconnaissance des REFE déficitaires chez les patients présentant un EDM résistant à un antidépresseur.
    - L'objectif de l'utilisation d'une tâche de décision lexicale sera de rechercher s’il existe un déficit du traitement automatique émotionnel chez les patients souffrant d’EDM.
    - Préciser les données concernant les processus attentionnels de reconnaissance des émotions de base.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pour les patients

    - Sujets volontaires répondant au diagnostic d’épisode dépressif majeur (EDM) selon les critères du DSM-IV (A.P.A 1994).
    - Hommes et femmes âgés de plus de 18 ans présentant un épisode dépressif majeur (critères DSM-IV), isolé ou récurrent.
    - Scores à l’échelle HDRS-17 > 22
    - Critère de résistance défini comme l’échec d’un traitement antidépresseur à dose efficace pendant une durée minimale de six semaines.
    - Consentement éclairé signé par le patient
    - Affiliation au régime de la sécurité sociale.


    Pour les volontaires sains
    - Hommes et femmes âgés de plus de 18 ans
    - Sujet indemne de toute pathologie
    - Consentement éclairé signé par le patient
    - Affiliation au régime de la sécurité sociale.
    E.4Principal exclusion criteria
    - Trouble bipolaire de type I ou type II (notion d’épisodes maniaques ou hypomaniaque)
    - Dépression avec caractéristiques psychotiques.
    - Echec antérieur d’un traitement par Venlafaxine pour cet épisode.
    - Diagnostic comorbide selon l’axe I (DSM IV) de schizophrénie, abus d’alcool et / ou de substances toxiques.
    - Malade hospitalisé sous contrainte ou sous mesure de protection juridique (tutelle, curatelle)
    - Contre indications à la pratique de la SMTr : antécédents personnels de crise convulsive, antécédents de pathologies neurologiques ou neurochirurgicales, matériel prothétique métallique ou corps étrangers (pacemaker, matériel prothétique oculaire, etc.).
    - Grossesse ou allaitement en cours. Un dosage des βHCG sera réalisé avant l’entrée dans le protocole, les patientes devront avoir un moyen de contraception tout au long de l’étude. Tout retard de règles relève au cours du suivi fera l’objet d’un contrôle du taux des βHCG.
    - Affection somatique susceptible d’affecter les capacités cognitives et les structures cérébrales (ex : infection par le VIH, SEP, lupus, maladie de Parkinson, épilepsie, démences…)
    - Hypersensibilité à la substance active ou à l’un des excipients de l’Effexor ®
    - Traitement par un IMAO datant de moins de 14 jours avant l’inclusion

    - Critères de non-inclusion ophtalmologique :
    * Déficience d’acuité visuelle de près et de loin
    * Déficit au test de réfractométrie
    * Déficit de vision des contrastes
    E.5 End points
    E.5.1Primary end point(s)
    Pourcentage de réponses correctes de reconnaissance des expressions faciales émotionnelles produit par les patients pour chacune des conditions expérimentales testées (J-3, J4, fin de phase 1 et à M+12 en rémission).
    L’analyse des performances de REFE sera comparée de façon longitudinale (donc en intra-sujets) mais aussi de façon transversale par rapport au groupe témoins (en inter-sujets) au cours des 4 séances de SMTr décrites ci-dessus.
    La répétition des tests de façon rapprochée induit un phénomène d'apprentissage à prendre en compte au cours de l'étude. Afin de limiter cet effet, les tests seront effectués dans une population témoin selon le même protocole que celui des patients. La comparaison des données intergroupes permettra de limiter ce phénomène d'apprentissage.

    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    Psychological
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    E.8.2.3.1Comparator description
    Magnetic transcranial stimulation
    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 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
    The end of the trial is the last visit of the last subject
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years0
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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) Yes
    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 No
    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.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)
    Not different from the expected norma treatment
    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 Decision2009-10-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2009-09-07
    P. End of Trial
    P.End of Trial StatusOngoing
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