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    Summary
    EudraCT Number:2014-005352-25
    Sponsor's Protocol Code Number:ML11283
    National Competent Authority:Belgium - FPS Health-DGM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-04-24
    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 ConcernedBelgium - FPS Health-DGM
    A.2EudraCT number2014-005352-25
    A.3Full title of the trial
    The effect of oxytocin on the training of attachment-related interpretation bias
    Het effect van oxytocine op het trainen van gehechtheid gerelateerde interpretatie bias
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effect of oxytocin on spontaneous interpretations of ambiguous maternal behavior
    Het effect van oxytocine op spontane interpretaties over ambigue moederlijk gedrag
    A.3.2Name or abbreviated title of the trial where available
    Oxytocin and attachment-related interpretation bias
    Oxytocine en gehechtheidsgerelateerde interpretatie bias
    A.4.1Sponsor's protocol code numberML11283
    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 SponsorKU Leuven
    B.1.3.4CountryBelgium
    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 supportKU Leuven
    B.4.2CountryBelgium
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationKU Leuven
    B.5.2Functional name of contact pointSimon De Winter
    B.5.3 Address:
    B.5.3.1Street AddressLeopold Vanderkelenstraat 32 - bus 3765
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.4Telephone number+3201637 30 95
    B.5.6E-mailsimon.dewinter@ppw.kuleuven.be
    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 (oxytocin), nasal spray 40 IE/ml
    D.2.1.1.2Name of the Marketing Authorisation holderDefiante Farmacêutica, S.A.
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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 (oxytocin)
    D.3.2Product code RVG 03716
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOxytocin
    D.3.9.1CAS number 50-56-6
    D.3.9.2Current sponsor codeML11283
    D.3.9.3Other descriptive nameOXYTOCIN
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 Yes
    D.3.11.13.1Other medicinal product typePharmaceutical
    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 placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    General population children (ages 8 - 13 years old)
    Kinderen uit de algemene populatie (tussen 8 en 13 jaar oud)
    E.1.1.1Medical condition in easily understood language
    General population children
    Kinderen uit de algemene populatie
    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
    In previous research we have demonstrated that it is possible to train children to interpret ambiguous maternal behavior in a positive manner, using a computerbased training task. Results showed that this positive interpretation bias led to an increase in children's trust in maternal support, one of the core concepts of attachment.
    In the current study, we want to investigate whether we can increase the training effect using oxytocin. Oxytocin is a substance that has been associated with social learning, trust, and attachment. Thus, it seems like a prime candidate to increase the training effect.
    Children will be administered either a single dose of oxytocin or a placebo substance and then complete either the experimental or the placebo training. This will allow us to examine whether oxytocin results in significantly more positive training effect.
    In voorgaand onderzoek door onze onderzoeksgroep werd reeds aangetoond dat het mogelijk is om met behulp van een computergestuurde training kinderen te leren om ambigue gedrag van moeder op een positieve manier te interpreteren. Deze positieve interpretatie bias zorgde voor een toename in het vertrouwen van kinderen in steun van hun moeder.
    De opzet van het huidige onderzoek is om na te gaan of dit trainingseffect versterkt kan worden door het gebruik van oxytocine. Oxytocine is een stof die meermaals in verband is gebracht met sociaal leren, vertrouwen en gehechtheid. Oxytocine lijkt daarom een uitstekende kandidaat om het trainingseffect te versterken.
    Kinderen zullen een éénmalige dosis van ofwel oxytocine ofwel een placebo toegediend krijgen en zullen daarna ofwel de werkzame training ofwel een placebo training doorlopen. Op deze manier kan nagegaan worden of het gebruik van oxytocine tot een groter effect van de training leidt.
    E.2.2Secondary objectives of the trial
    Not applicable.
    Niet van toepassing.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General population children between the age of 8 and 13 years old.
    Algemene populatie kinderen tussen 8 en 13 jaar oud.
    E.4Principal exclusion criteria
    Participants will be excluded based on the following criteria:

    - Known oxytocin allergy
    - Currently using medication
    - Kidney or Cardial condition
    Participanten zullen uitgesloten worden op basis van de volgende criteria:

    - Gekende oxytocine allergie
    - Op het moment van het onderzoek gebruik maken van medicatie
    - Nier- of Hartproblemen
    E.5 End points
    E.5.1Primary end point(s)
    This study will provide information on the role of oxytocin in middle childhood attachment and, more specifically, attachment-related interpretation bias. Furthermore, this study might identify oxytocin as a substance that can further improve the positive effects of our training, thus further improving the clinical relevance of our training.
    Thus, the anticipated end point is an increase in children's attachment security and a more positive interpretation bias.
    Deze studie zal informatie verschaffen over de rol van oxytocine in gehechtheid van lagere schoolkinderen en, specifieker, in gehechtheidsgerelateerde interpretatie bias. Verder kan deze studie mogelijk oxytocine identificeren als een substantie die de positieve effecten van onze training versterkt, waardoor de klinische relevantie van onze training kan toenemen.
    Het verwachte eindpunt is een stijging in de veilige gehechtheid van de kinderen en een meer positieve interpretatie bias.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of the trial is anticipated August 2016.
    Het einde van deze trial is voorzien op augustus 2016.
    E.5.2Secondary end point(s)
    Not applicable
    Niet van toepassing
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    Niet van toepassing
    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 Yes
    E.6.13.1Other scope of the trial description
    Investigate the effect of oxytocin on the training for positive attachment-related interpretation bias
    Het effect van oxytocine onderzoeken op de training voor positieve gehechtheidsgerelateerde interpretatie bias
    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 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.8.2.4Number 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
    Last visit of the last participant.
    Every participant will come to the lab only once and will thus only once be adminstered oxytocin or the placebo substance.
    Laatste bezoek van de laatste participant.
    Elke participant komt slechts één keer naar het labo en zal dus ook maar één keer oxytocine of de placebo worden toegediend.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months4
    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 Yes
    F.1.1Number of subjects for this age range: 100
    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) Yes
    F.1.1.5.1Number of subjects for this age range: 75
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 25
    F.1.2Adults (18-64 years) No
    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 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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Because we are working with children from age 8 - 13 years old, we will always require both the consent of the child and the parents.
    Omdat we werken met kinderen tussen 8 en 13 jaar oud, hebben we steeds de toestemming van het kind en de ouders nodig.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state100
    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)
    Results and study outcome will be communicated to the participants.
    No treatment or care is required after the participant has ended his participation in the trial.
    If necessary, medical assistance can be provided by one of the co-promotors of this study.
    Resultaten en studie uitkomsten zullen gecommuniceerd worden naar de participanten.
    Geen behandeling is nodig nadat de participant de studie heeft afgrond.
    Indien noodzakelijk, kan medische bijstand verleend worden door één van de co-promotoren van het onderzoek.
    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 Decision2015-06-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-07
    P. End of Trial
    P.End of Trial StatusOngoing
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