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    Summary
    EudraCT Number:2013-000029-29
    Sponsor's Protocol Code Number:P/2013/160
    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:2015-09-15
    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 number2013-000029-29
    A.3Full title of the trial
    Study of the effect of oxytocin on emotion regulation in adolescents with insecure attachment
    Etude de l'effet de l'ocytocine sur la régulation émotionnelle chez des adolescents à l’attachement insécure
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of the effect of oxytocin on emotion regulation in adolescents with insecure attachment
    Etude de l'effet de l'ocytocine sur la régulation émotionnelle chez des adolescents à l’attachement insécure
    A.3.2Name or abbreviated title of the trial where available
    ELOREA
    ELOREA
    A.4.1Sponsor's protocol code numberP/2013/160
    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 SponsorCentre Hospitalier Régional Universitaire de Besancon
    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 supportCHRU de Besançon
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDRCI
    B.5.2Functional name of contact pointChef de projet
    B.5.3 Address:
    B.5.3.1Street Address2, place St-Jacques
    B.5.3.2Town/ cityBesançon
    B.5.3.3Post code25030
    B.5.3.4CountryFrance
    B.5.4Telephone number0381218745
    B.5.5Fax number0381218595
    B.5.6E-mailsdepierre@chu-besancon.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 syntocinon
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSwitzerland
    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 namesyntocinon
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInhalation 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 placeboNasal spray
    D.8.4Route of administration of the placeboInhalation use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Effet de l'ocytocine sur la régulation émotionnelle d'adolescents de sexe masculin, volontaires sain.
    E.1.1.1Medical condition in easily understood language
    Effet de l'ocytocine sur la régulation émotionnelle d'adolescents de sexe masculin, volontaires sain.
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Psychological processes [F02]
    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
    évaluer l’effet de l’ocytocine par inhalation nasale sur les stratégies visuelles d’exploration des images sollicitant l’attachement (détresse et réconfort) chez des adolescents insécures. Cette caractérisation se basera sur l’étude de paramètres oculomoteurs.
    E.2.2Secondary objectives of the trial
    évaluer l’effet de l’ocytocine sur les réactions émotionnelles physiologiques suscitées par la visualisation d’images. et par la perception d’odeur dans cette même population.
    - évaluer l’effet de l’ocytocine sur le comportement et le discours de l’adolescent insécure lors d’une discussion avec son parent concernant un sujet de désaccord (situation stressante
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Adolescents de sexe masculin
    Scolarisés au lycée et au collège
    Non hospitalisés
    Agés de 13 ans à 18 ans
    E.4Principal exclusion criteria
    sexe féminin
    Déficit intellectuel
    Ne parlant pas français
    Pathologies des voies nasales
    Troubles visuels
    Consommation massive de tabac pouvant altérer la sensibilité olfactive (supérieure à 20 cigarettes par jour)
    E.5 End points
    E.5.1Primary end point(s)
    Il s’agit d’une différence significative de durée totale de fixation sur les images de réconfort entre les participants ayant reçu traitement par ocytocine et ceux ayant reçu le traitement par placebo.
    E.5.1.1Timepoint(s) of evaluation of this end point
    visite 4
    E.5.2Secondary end point(s)
    - Il s’agit d’une différence significative de durée totale de fixation sur les images de détresse, de temps de latence et de lieu de la première fixation ainsi que le nombre de fixations et la durée moyenne de fixation sur chacune des images entre les participants ayant reçu le traitement par ocytocine et ceux ayant reçu le traitement par placebo .
    - il s’agit d’une différence significative de paramètres neurovégétatifs (réaction électrodermale, pouls, intervalle RR) entre les participants ayant reçu le traitement par ocytocine et ceux ayant reçu le traitement par placebo.
    - il s’agit d’une différence significative d’indice de sévérité de confusion des rôles parentales et de type de comportement désorganisé de l’adolescent lors de l’interaction mère-adolescent entre les participants ayant reçu le traitement par ocytocine et ceux ayant reçu le traitement par placebo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    visite 4
    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
    Effet
    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 No
    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.8.2.4Number 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 years2
    E.8.9.1In the Member State concerned months0
    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 Yes
    F.1.1Number of subjects for this age range: 26
    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) Yes
    F.1.1.6.1Number of subjects for this age range: 26
    F.1.2Adults (18-64 years) No
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 state26
    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 Decision2013-08-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-30
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-10
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