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    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   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:2013-003888-59
    Sponsor's Protocol Code Number:C.2524.0493.01
    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:2014-01-17
    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 number2013-003888-59
    A.3Full title of the trial
    ADHD: Medication or Meditation?
    ADHD: Medicatie of Meditatie?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    My child has ADHD: Medication or Meditation?
    Mindfulness training versus medication in the treatment of childhood ADHD
    Mijn kind heeft ADHD: Medicatie of Meditatie?
    Mindfulness training verus medicatie in de behandeling van ADHD bij kinderen
    A.4.1Sponsor's protocol code numberC.2524.0493.01
    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 SponsorUniversity of Amsterdam
    B.1.3.4CountryNetherlands
    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 supportNetherlands Organisation for Scientific Research
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Amsterdam
    B.5.2Functional name of contact pointResearch Institute
    B.5.3 Address:
    B.5.3.1Street AddressNieuwe Prinsengracht 130
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1018 VZ
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031205251262
    B.5.5Fax number0031205251200
    B.5.6E-maile.i.debruin@uva.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 Ritalin (methylphenidate)
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma B.V.
    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 nameRitalin
    D.3.2Product code RVG 03957
    D.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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) 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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention Deficit Hyperactivity Disorder (ADHD)
    Aandachtstekortstoornis met Hyperactiviteit (ADHD)
    E.1.1.1Medical condition in easily understood language
    ADHD
    ADHD
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]
    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
    The main objective of this trial is to study the effects of mindfulness training combined with Mindful Parenting training versus methylphenidate in children and youngsters with ADHD on outcome measures of attention, hyperactivity and impulsivity.
    Het primaire doel van deze studie is om de effecten van mindfulness training gecombineerd met Mindful Parenting training versus methylfenidaat te onderzoeken in kinderen en jongeren met ADHD op uitkomstmaten van aandacht, hyperactiviteit en impulsiviteit.
    E.2.2Secondary objectives of the trial
    A seondary aim of this study is to evaluate the cost-effectiveness of mindfulness training + Mindful Parenting training as compared to methylphenidate in this group of children.
    Een tweede doel van deze studie is om de kosteneffectiviteit te evalueren van mindfulness training + Mindful Parenting training vergeleken met methylfenidaat bij deze groep kinderen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - The child is between 9 and 18 years of age
    - The child has a DSM classification of ADHD
    - ADIS-C is administered
    - (Estimated) IQ > 80
    - At least one parent is willing to participate in the Mindful Parenting training
    - Het kind is tussen de 9 en 19 jaar oud
    - Het kind heeft een DSM classificatie ADHD
    - ADIS-C wordt afgenomen
    - (Geschat) IQ > 80
    - Tenminste een ouder is bereid deel te nemen aan de Mindful Parenting training
    E.4Principal exclusion criteria
    - (Estimated) IQ < 80
    - Suicidal ideation
    - Suffering from psychosis or schizophrenia
    - Co-morbid autism or Conduct Disorder
    - Current or previous use of methylphenidate
    - Participation in a currently active other psychological intervention
    - (Geschat) IQ < 80
    - Suicidale ideaties
    - Lijden aan psychose of schizofrenie
    - Co-morbide autisme of Conduct Disorder
    - Huidig of eerder gebruik van methylfenidaat
    - Deelname aan huidig lopende actieve andere psychologische interventie
    E.5 End points
    E.5.1Primary end point(s)
    Our primary outcome measure is attention, hyperactivity and impulsivity in the child.
    Onze primaire uitkomstmaat is aandacht, hyperactiviteit en impulsiviteit bij het kind.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Directly after the last participant finished his/her treatment
    Direct na het einde van de laatste behandeling van de laatste patient
    E.5.2Secondary end point(s)
    Secondary outcome measures are symptoms of anxiety and depression, sleep, parents own symptomatology, parental stress and mindfulness.
    Secundaire uitkomstmaten zijn symptomen van angst en depressie, slaap, ouders' eigen symptomatologie, ouderlijke stress en mindfulness.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Directly after the last participant finished his/her treatment
    Direct na het einde van de laatste behandeling van de laatste patient
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 No
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Mindfulness Training
    Mindfulness Training
    E.8.2.4Number of treatment arms in the trial2
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA2
    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
    LVLS
    LBLP
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 120
    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: 60
    F.1.1.6Adolescents (12-17 years) Yes
    F.1.1.6.1Number of subjects for this age range: 60
    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 No
    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 state120
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 120
    F.4.2.2In the whole clinical trial 120
    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)
    Children and parents may continue treatment after the trial if they wish so
    Kinderen en ouders kunnen behandeling voortzetten na de trial als ze dat willen
    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 Decision2014-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-03-17
    P. End of Trial
    P.End of Trial StatusOngoing
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