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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43851   clinical trials with a EudraCT protocol, of which   7283   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:2008-002002-19
    Sponsor's Protocol Code Number:MODAGE MO 169
    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:2008-05-05
    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 number2008-002002-19
    A.3Full title of the trial
    Effets du moclobémide sur le profil d'activation cérébrale de patients dépressifs âgés lors de tâches cognitives et émotionnelles, en référence à des sujets témoins. Etude ouverte, multicentrique, chez le patient âgé présentant un épisode dépressif majeur et traité par moclobémide pendant 6 semaines
    A.4.1Sponsor's protocol code numberMODAGE MO 169
    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 SponsorBIOCODEX
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    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 MOCLAMINE 150 mg comprimé pelliculé sécable
    D.2.1.1.2Name of the Marketing Authorisation holderBIOCODEX
    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 nameMOCLAMINE
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    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) 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 Information not present in EudraCT
    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
    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
    Evaluer, chez des patients dépressifs âgés, l'effet du moclobémide sur l'activation cérébrale lors de tâches d'appariement et de reconnaissance des émotions, à l'aide d'un examen d'imagerie par résonance magnétique fonctionnelle (IRMf) réalisé avant puis après 6 semaines de traitement.
    E.2.2Secondary objectives of the trial
    Comparer l'activation cérébrale des patients avec celle de sujets témoins appariés
    Comparer chez les patients et les sujets témoins, l'évolution des profils d'activation à 6 semaines par rapport aux profils d'activation à l'inclusion.
    Comparer l'activation cérébrale des patients lors de la tâche d'induction émotionnelle en fonction des dimensions symptomatiques de la dépression, du ralentissement et des performances aux tests cognitifs et attentionnels.
    Comparer les symptômes dépressifs et le fonctionnement cognitif et émotionnel entre les patients avant et après traitement et entre les patients et les sujets témoins.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Pour les patients
    - Homme ou femme agé(e) de 60 ans et plus
    - Présentant un Episode Dépressif Majeur selon les critères du DSM IV et ayant un score GDS > 10.
    - Nécessitant la prescription d'un traitement médicamenteux antidépresseur.
    - Patient(e) ou son représentant légal ayant donné par écrit son consentement libre et éclairé.
    - Bénéficiant d'un régime de protection sociale.

    Pour les sujets témoins

    Homme ou femme, de 60 ans et plus, d'âge, de sexe et de niveau socio-éducatif comparables aux patients inclus
    dont l'examen clinique ne montre pas d'anomalie significative
    ne présentant pas un diagnostic d'affection mentale établi selon le DSM IV et l'évaluation du MINI et n'ayant pas de score GDS > 10, ni d'affection neurologique.
    Ne présentant pas d'antécédent psychiatrique ou neurologique et indemne de tout traitement par neuroleptiques ou antidépresseurs depuis 3 mois
    Acceptant de participer à l'étude après avoir lu le document écrit d'information et signé le formulaire de consentement
    bénéficiant d'un régime de protection sociale
    E.4Principal exclusion criteria
    Pour les patients :
    hypersensibilité connue au moclobémide ou à l'un de ses excipients
    état confusionnel aigu
    recevant un médicament contre indiqué avec l'usage du moclobémide : sélégiline, dextrométorphane, péthidine, tramadol, bupropion, triptans (sumatriptan, rizatriptan, almotriptan, zolmitriptan)
    recevant un traitement antidépresseur ou ayant reçu un médicament antidépresseur interrompu dans un délai inférieur à 5 demi-vies du médicament ou ayant été traité par ECT (électroconvulsivothérapie) dans les 15 jours précédant la visite de sélection.
    Affection somatique ou neurologique grave, maladie cardio vasculaire, hépatique, ou rénale sévère ou pathologie mettant en jeu le pronostic vital dans les trois mois.
    Patient ne pouvant interrompre un traitement en cours risquant d'interférer soit avec la thérapeutique soit avec son état psychique (corticothérapie, anti-parkinsoniens, anti-tuberculeux, anti-mitotiques)
    contre indication à l'IRMf
    patients gauchers

    Pour le sujets témoins

    Recevant un traitement antidépresseur
    démence dégénérative, vasculaire ou secondaire
    affection somatique ou neurologique grave, maladie cardio-vasculaire, hépatique, ou rénale sévère ou pathologie mettant en jeu le pronostic vital dans les 3 mois
    contre-indication à l'IRMf
    sujet gaucher
    refusant d'être inscrit sur le Fichier national des personnes qui se prêtent à des recherches biomédicales ou en période d'exclusion sur ce fichier
    E.5 End points
    E.5.1Primary end point(s)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned7
    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 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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    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 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 state40
    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 Decision2008-05-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-06-11
    P. End of Trial
    P.End of Trial StatusOngoing
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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