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    Summary
    EudraCT Number:2012-005246-38
    Sponsor's Protocol Code Number:143660
    National Competent Authority:Norway - NOMA
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2013-02-07
    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 ConcernedNorway - NOMA
    A.2EudraCT number2012-005246-38
    A.3Full title of the trial
    The effects of methylphenidate on brain processes for decision making in adult attention deficit hyperactivity disorder
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of Ritalin treatment on decision making and learning, and on brain activation, in adult ADHD
    A.4.1Sponsor's protocol code number143660
    A.5.4Other Identifiers
    Name:Regional Ethics Commitees - behavioural studyNumber:2011/1585
    Name:Regional Ethics Commitees - fMRI studyNumber:2012/1105
    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 Oslo
    B.1.3.4CountryNorway
    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 supportSouth-Eastern Norway Regional Health Authority
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportNorwegian Research Council
    B.4.2CountryNorway
    B.4.1Name of organisation providing supportUniversity of Oslo
    B.4.2CountryNorway
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity of Oslo
    B.5.2Functional name of contact pointGuido Biele
    B.5.3 Address:
    B.5.3.1Street AddressForskningsveien 3A
    B.5.3.2Town/ cityOslo
    B.5.3.3Post code0373
    B.5.3.4CountryNorway
    B.5.4Telephone number+4722845172
    B.5.5Fax number+4722845096
    B.5.6E-mailg.p.biele@psykologi.uio.no
    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 Ritalin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Norge AS, Oslo, Norway
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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.3.4Pharmaceutical 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.IMP: 2
    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 Ritalin
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis AS, Oslo, Norway
    D.2.1.2Country which granted the Marketing AuthorisationNorway
    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.3.4Pharmaceutical form Capsule
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboTablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Attention deficit hyperactivty disorder
    E.1.1.1Medical condition in easily understood language
    ADHD
    E.1.1.2Therapeutic area Psychiatry and Psychology [F] - Behaviours [F01]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 15.1
    E.1.2Level PT
    E.1.2Classification code 10003736
    E.1.2Term Attention deficit/hyperactivity disorder
    E.1.2System Organ Class 10037175 - Psychiatric disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To investigate the effects of methylphenidate on behavioural processes and brain mechanisms involved in decision making and instrumental in adults with ADHD. We will be testing patients on and off their already prescribed medication dose while they are performing a value-based decision making task and/or an instrumental learning task, either in an MRI-scanner (to document the effects of methylphenidate on decision making and the brain processes associated with this) or without MRI in a pure behavioural arm.
    E.2.2Secondary objectives of the trial
    To evaluate the effect of methylphenidate on cerebral perfusion in adult ADHD, measured by an Arterial Spin Labeling MRI-technique. This part of the study will also investigate drug-naïve patients before medication start-up.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    The prospective patient participants at screening prior to receiving study agent must meet all of the following conditions:
    • Comply with DSM-IV criteria for ADHD.
    • On stable treatment with MPH.
    • Must be between the age of 18 and 40.
    • Signed informed consent and expected cooperation of the patients for the intervention and the test dates must be obtained and documented according to ICH GCP, and national/local regulations.


    One subgroup of the study will be drug-naïve ADHD patients, before they start medical treatment (newly diagnosed and awaiting approval from cardiologist to start drug treatment). After medication start, these patients will be recruited to continue the experiment as the other participants.
    E.4Principal exclusion criteria
    • Treatment with the following groups of pharmacological agents will be considered as exclusion criteria for participation:
    • Antidepressants (MOA-inhibitors, Tricyclic antidepressants, SSRIs)
    • Antipsychotics (both first and second generation)
    • Anxiolytics/hypnotics (benzodiazepines, barbiturates)
    • Opiates
    • History of alcohol or drug abuse.
    • History of moderate to severe head injury.
    • Major psychiatric comorbidity (i.e. psychosis, active suicidal ideation or acute exacerbation of other psychiatric condition in need of immediate treatment).
    • Epilepsy
    • History of severe memory loss
    • Under treatment for metabolic disorders
    • Severe primary sensory loss
    • Any condition contraindicating treatment with methylphenidate will automatically lead to exclusion, since these patients will not receive methylphenidate from clinician and thus will not meet inclusion criteria (including pregnancy, methylphenidate allergies, incompatible concomitant medication etc.).

    • MRI specific criteria: contraindications for MRI (i.e. metallic or circuit-containing implants, severe claustrophobia
    E.5 End points
    E.5.1Primary end point(s)
    1) Attention to negative outcomes, measured as the impact of the cost-dimension of options on choice behaviour in the cost/benefit DM-task (CBDM, Basten et al. 2010).
    2) Impulsiveness, measured as consistency of choosing and reaction times in the CBDM.
    3) Memory of recent outcomes, measured as the learning rate of a reinforcement learning model fitted to participants behaviour (Yachiam at al, 2005).
    4) Erratic choosing, measured as the sensitivity parameter of the choice rule in the reinforcement learning model (Yechiam et al, 2005).
    5) Reliability of the neural gain- and loss-signals, measured as the correlation between the magnitude of gain- and loss-values in the options presented in the CBDM-task and the BOLD-response in the ventral striatum (gains) and the amygdala (losses), respectively.
    6) Integration of gains and losses into a neural decision signal, measured as correlation of the the difference of the neural loss signal in the amygdala and the neural gain signal in the nucleus accumbens with the BOLD response in the VMPFC (Basten et al, 2010).
    7) Predictive power of change in the latent parameters of DM and instrumental learning described in 1-4 after single-dose MPH-challenge for the clinical efficacy of MPH in specific patients.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Each participant will be scanned twice, once on and once off medication.

    Drug-naïve participants will be scanned three times: first as drug-naïve and then included in the regular trial course and scanned on and off medication after achieving stable treatment.

    Effect of disease and medication will be checked after completion of all testing sessions for each participant. Statistical significance testing will be done after all last visit of last participant.
    E.5.2Secondary end point(s)
    8) Cerebral blood flow (CBF) in the dopaminergic mesolimbic system, as measured by arterial spin labeling (ASL) MRI.
    9) Predictive power of change in CBF-measurements after single-dose MPH-challenge for the clinical efficacy of MPH in specific patients.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Each participant will be scanned twice, once on and once off medication.

    Drug-naïve participants will be scanned three times: first as drug-naïve and then included in the regular trial course and scanned on and off medication after achieving stable treatment.

    Effect of disease and medication will be checked after completion of all testing sessions for each participant. Statistical significance testing will be done after all last visit of last participant.
    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 Yes
    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
    Psychological: effects on cognition.

    Neural: effects on brain mechanisms associated with decision making.

    Perfusion: Effects of medication and disease on resting cerebral perfusion.
    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 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 Yes
    E.8.2.3.1Comparator description
    Healthy controls without treatment
    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
    LVLS
    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 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: 150
    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 Yes
    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 2013-02-07. 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 state150
    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)
    Patients with ADHD will be carefully monitored by treating clinician with respect to gambling behaviour. The Regional Commitees for Medical and Health Research Ethics in our region have made this point mandatory after considering our study.

    All medical decisions concerning the patient participants' health will be dealt with by treating physician, and PI of this trial, Mats Fredriksen. No other treatment intervention but the 12 to 24 hour cessation before testing is done for this trial.
    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 Decision2013-05-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-08-30
    P. End of Trial
    P.End of Trial StatusOngoing
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