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    Summary
    EudraCT Number:2022-000156-11
    Sponsor's Protocol Code Number:S65914
    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:2022-01-27
    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 number2022-000156-11
    A.3Full title of the trial
    Oxytocin and the development of attachment: Looking beyond the expected?
    Oxytocine en de ontwikkeling van gehechtheid: een blik voorbij de verwachting?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Oxytocin and the development of attachment: Looking beyond the expected?
    Oxytocine en de ontwikkeling van gehechtheid: een blik voorbij de verwachting?
    A.4.1Sponsor's protocol code numberS65914
    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 supportFWO
    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 pointSamuel Budniok
    B.5.3 Address:
    B.5.3.1Street AddressTiensestraat 102 - bus 3720
    B.5.3.2Town/ cityLeuven
    B.5.3.3Post code3000
    B.5.3.4CountryBelgium
    B.5.6E-mailsamuel.budniok@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 holderAlfasigma S.p.A.
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntranasal use (Noncurrent)
    Nasal 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 codeS65914
    D.3.9.3Other descriptive nameOXYTOCIN
    D.3.9.4EV Substance CodeSUB09580MIG
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    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 healthy population children (ages 8 - 13 years old).
    Gezonde kinderen uit de algemene populatie (tussen 8 en 13 jaar oud).
    E.1.1.1Medical condition in easily understood language
    General population children (ages 8 - 13 years old).
    Gezonde kinderen uit de algemene populatie (tussen 8 en 13 jaar oud).
    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 the current study, we use principles of the Learning Theory of Attachment (LTA), which
    proposes that the development of attachment can be partly explained as a result of a learning
    process, to investigate the role of oxytocin in the development of attachment. Previous research
    found that oxytocin attenuates prediction error which suggests that oxytocin can affect plasticity.
    Based on the LTA, we specify concrete hypotheses and by manipulating contingency in
    different trials, we can assess how oxytocin affects trust learning on a trial-by-trial basis.
    Furthermore, we want to assess whether the effect of oxytocin also extends to a more basic level. Secondly, because of the potential attenuating effect of oxytocin on the encoding of prediction error, we will focus on the dopamine system as explanatory mechanism. Previous research pointed to a crucial role for the dopamine system in updating of safety conditioning and encoding prediction error.
    In deze studie baseren we ons op de "Learning Theory of Attachment (LTA)" om de rol van oxytocine in de ontwikkeling van gehechtheid te onderzoeken. Deze theorie stelt dat de ontwikkeling van gehechtheid gedeeltelijk verklaard kan worden als resultaat van een leerproces. Eerder onderzoek vond dat oxytocine predictiefouten vermindert, wat suggereert dat oxytocine plasticiteit kan beïnvloeden. Gebaseerd op de LTA, kunnen we concrete hypotheses maken en door het manipuleren van contingentie in verschillende trials, kunnen we nagaan hoe oxytocine het leren van vertrouwen beïnvloedt. Verder willen we nagaan of het effect van oxytocine ook een meer basaal niveau van leren beïnvloedt. Ten tweede, vanwege het mogelijke effect van oxytocine op het verwerken van predictiefouten, zullen we ons richten op het dopaminesysteem als verklarend mechanisme. Eerder onderzoek wees op een cruciale rol van het dopaminesysteem bij het updaten van "safety conditioning" en het verwerken van predictiefouten.
    E.2.2Secondary objectives of the trial
    Not applicable.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    General population children between the age of 8 and 13 years old.
    Gezonde kinderen uit de algemene populatie tussen 8 en 13 jaar oud.
    E.4Principal exclusion criteria
    - Participant has a history of an oxytocin allergy
    - Any disorder, which in the Investigator’s opinion might jeopardise the participant’s safety or
    compliance with the protocol
    - Any prior or concomitant treatment(s) that might jeopardise the participant’s safety or that
    would compromise the integrity of the Trial
    - Participation in an interventional Trial with an investigational medicinal product (IMP) or device
    - A kidney or cardial condition.
    - Participant is taking any medication at the time of testing.
    - Participant heeft een geschiedenis van een oxytocine allergie
    - Elke stoornis die naar de mening van de onderzoeker de veiligheid van de participant in gevaar kan brengen of ervoor kan zorgen dat het protocol niet naar behoren kan uitgevoerd worden.
    - Elke vorige of huidige behandeling die de participant in gevaar kan brengen of ervoor kan zorgen dat het protocol niet naar behoren kan uitgevoerd worden.
    - De participant doet mee aan een andere trial waarin een IMP of toestel getest wordt.
    - Hart- of nierziekte.
    - De participant neemt medicatie op het moment van testen.
    E.5 End points
    E.5.1Primary end point(s)
    This study will provide information on the effects of oxytocin during trust learning as well as
    during a more basic level of learning (cognitive flexibility). Furthermore, this study might identify
    the dopamine system as neural system through which oxytocin exerts its effects. The anticipated
    end point is that oxytocin will have an attenuating effect on both trust learning and basic learning
    which possibly will be explained by the dopamine system.
    Deze studie zal informatie opleveren over de effecten van oxytocine tijdens het leren van vertrouwen alsook tijdens een meer basaal niveau van leren (cognitieve flexibiliteit). Verder zou deze studie het dopaminesysteem kunnen identificeren als neuraal systeem dat de effecten van oxytocine verklaart. Het geanticipeerde eindpunt is dat oxytocine een verzwakkend effect zal hebben op zowel het leren van vertrouwen als op een meer basaal niveau van leren. Deze effecten zullen mogelijks door het dopaminesysteem verklaard worden.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The trial is anticipated to end at the end of 2025.
    We verwachten dat deze trial eindigt eind 2025.
    E.5.2Secondary end point(s)
    Not applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    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
    Investigate the effect of oxytocin on trust learning and a more basic level of learning and whether
    this effect can be explained by the dopamine system.
    De effecten van oxytocine onderzoeken op het leren van vertrouwen en op een meer basaal niveau van leren en of deze effecten verklaard kunnen worden door het dopaminesysteem.
    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 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 administered oxytocin or the placebo substance.
    Laatste bezoek van de participant. Elke participant komt 1 keer naar het lab en zal dus 1 keer oxytocine of placebo toegediend krijgen.
    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 Yes
    F.1.1Number of subjects for this age range: 200
    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: 100
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 100
    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 Yes
    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, zullen we altijd vragen om toestemming van zowel kind als ouders.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state200
    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 investigators of this study. Participants will be called and asked about any side
    effects 3 days after the day they were tested.
    Resultaten en uitkomsten van de studie zullen gecommuniceerd worden aan de participanten. Er is geen behandeling of zorg nodig nadat de participant de trial heeft beëindigd. Indien nodig kan er medische assistentie verleend worden door één van de onderzoekers. Participanten zullen 3 dagen na deelname gebeld en bevraagd worden naar eventuele bijwerkingen.
    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 Decision2022-02-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-02-25
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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