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    Summary
    EudraCT Number:2013-000454-22
    Sponsor's Protocol Code Number:NL43068.058.13
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-20
    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 ConcernedNetherlands - Competent Authority
    A.2EudraCT number2013-000454-22
    A.3Full title of the trial
    (Grand)parenting, oxytocin, and the oxytocin receptor gene: an fMRI and observational study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    (Grand)parenting, oxytocin, and the oxytocin receptor gene
    A.3.2Name or abbreviated title of the trial where available
    (Grand)parenting and oxytocin
    A.4.1Sponsor's protocol code numberNL43068.058.13
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    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
    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
    D.3.2Product code RVG03716
    D.3.4Pharmaceutical form Nasal spray
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPNasal use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 placeboNasal use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    There are no medical conditions or diseases under investigation
    E.1.1.1Medical condition in easily understood language
    not applicable
    E.1.1.2Therapeutic area Not possible to specify
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 14.1
    E.1.2Level PT
    E.1.2Classification code 10033329
    E.1.2Term Oxytocin
    E.1.2System Organ Class 10022891 - Investigations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Primary objective is to investigate:
    - effects of oxytocin on mothers’ and grandmothers’ neural activity related to empathic responding to their (grand)children. We expect oxytocin to decrease activity in brain areas associated with hyperarousal and fear, increase activity in brain regions associated with social cognition, and facilitate empathic responses. We expect changes in brain activity to be related to increases in empathy.
    - effects of oxytocin on mothers’ and grandmothers’ neural activity in response to stimuli designed to elicit protective responses; pictures of their own and other (grand)children preceded by a mildly threatening prime. We expect oxytocin to reduce amygdala activation, reflecting reduced arousal and fear thereby promoting adaptive (protective) responding.
    - effects of oxytocin on mothers’ and grandmothers’ sensitive responsiveness toward their (grand)children.
    - the role of the oxytocin receptor gene in moderating effects of administered oxytocin.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to investigate:
    - effects of oxytocin on grandmother-mother interactions.
    - the potential relations between the (grand)child’s rejection sensitivity and both mother’s and grandmother’s empathic responding to the child.
    - the potential relations between the grandmother’s, mother’s, and child’s level of empathic behavior.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    In order to be eligible to participate in this study, a subject must meet all of the following criteria:
    -Mothers: female adults having a 6-8 year old child and a mother willing to participate.
    -Grandmothers: female adults, whose daughter with a 6-8 year old child is willing to participate.
    -Children: 6-8 year old boys and girls.
    E.4Principal exclusion criteria
    A potential subject who meets any of the following criteria will be excluded from participation in this study:
    -Mothers, grandmothers, and children:
    o Any known neurological and (uncorrected) visual impairments
    o Psychiatric disorders
    -Mothers and grandmothers:
    o smoking
    o alcohol and drug abuse
    o pregnancy
    o breastfeeding
    o use of medication, except oral contraceptives
    o MRI contraindications
    E.5 End points
    E.5.1Primary end point(s)
    The main study parameters are:
    - Activity in brain areas associated with (hyper)arousal and fearfulness (notably the amygdala), as well as social cognition, attachment, and empathy (e.g., superior temporal cortex, inferior frontal gyrus, fusiform gyrus, insula). We will examine the effects of oxytocin on activity in these areas in both mothers and grandmothers during a priming task designed to elicit protective responses and during a cyberball task designed to elicit empathic responses and behavior. In addition, we will examine whether effects of oxytocin are moderated by the oxytocin receptor genotype.
    - Empathic behavior, i.e., compensatory ball throwing to an excluded participant, during the cyberball task. We will examine effects of oxytocin on empathic behavior in both grandmothers and mothers. In addition, we will examine the relation between oxytocin’s effects on empathic behavior and its affects on brain activity during the cyberball task.
    - Sensitive responsiveness toward the (grand)child. We will examine effects of oxytocin on both mothers’ and grandmothers’ sensitive responsiveness toward their (grand)child while working at a drawing together with the (grand)child. In addition we will examine whether effects of oxytocin are moderated by the oxytocin receptor genotype.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Participants will come to the laboratory for two identical experimental sessions, seperated by 4 weeks.
    E.5.2Secondary end point(s)
    Secondary study parameters are:
    -Interactive behavior of mother and grandmother during a family interaction task (FIT; Allen et al., 2003). We will examine the effects of oxytocin on grandmother-mother interactions. In addition we will examine whether effects of oxytocin are moderated by the oxytocin receptor genotype.
    -The child’s empathic behavior and rejection sensitivity. We will investigate potential relations between children’s, mothers’, and grandmothers’ levels of empathic behavior. We will investigate whether children’s rejection sensitivity is related to their mothers’ and grandmothers’ empathic behavior toward them during the cyberball game and to their mothers’ and grandmothers’ sensitive responsiveness toward them (under placebo conditions).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Secondary parameters will be assessed during the same two identical experimental sessions, seperated by 4 weeks.
    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
    With the proposed study we aim to gain insight into the effects of oxytocin (OT) on both parents’ and grandparents’ sensitive, empathic, and protective responses to their (grand)children, and in the neural origins of these responses.
    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 No
    E.8.1.6Cross over Yes
    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 subject undergoing the trial.
    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 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 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.1.2.1Number of subjects for this age range: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 25
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2013-02-20. Yes
    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 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)
    There is no medical or other treatment of any clinical problem or disorder involved during or after the study.
    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 Decision2013-02-20
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-08-21
    P. End of Trial
    P.End of Trial StatusOngoing
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