E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention-Deficit Hyperactivity Disorder (ADHD) |
Attention-Deficit Hyperactivity Disorder (ADHD) |
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E.1.1.1 | Medical condition in easily understood language |
Children that suffer from some combination of hyperactivity, impulsivity, and/or inattention. |
ADHD is ook wel bekend als 'Alle Dagen Heel Druk'; kinderen met ADHD lijden aan een combinatie van hyperactiviteit, impulsiviteit en/of aandachtsproblemen. |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Psychological processes [F02] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The main hypothesis we aim to address is that there are two mechanisms involved in behavioural control in ADHD, one proactive mechanism, regulated by DAT function in fronto-striatal networks, and one reactive mechanism regulated by COMT function in prefrontal cortex (SFG). Objective of the study: To address these research questions, this study has three primary and two secondary objectives. Primary Objectives: 1.1) Investigate differences in stop-ERP between good and poor responders to methylphenidate 1.2) Investigate differences in brain activation using fMRI between good and poor responders to methylphenidate 1.3) Investigate differences in the prevalence of DAT1 and COMT polymorphism between good and poor responders to methylphenidate
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Het doel van het onderzoek is,naar aanleiding van genoemd theoretisch kader, om te onderzoeken of twee kandidaat-genen in combinatie met EEG en fMRI markers verschillen tussen kinderen met ADHD die wel en niet klinisch responderen op MPH. De primaire uitkomstmaten van deze studie zijn: 1.) Stop-ERP verschillen tussen kinderen die wel en niet klinisch responderen op methylfenidaat. 2.) Verschillen in hersenactivatie tussen kinderen die wel en niet klinisch responderen op methylfenidaat. 3.) De prevalentie van de DAT1 en COMT polymorfismes tussen kinderen die wel en niet klinisch responderen op methylfenidaat.
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E.2.2 | Secondary objectives of the trial |
Secondary objectives: 2.1) Investigate differences in the coherence of brain activity from EEG signal 2.2) Investigate differences in connectivity between striatum/IFG/SFG from resting state fMRI signal
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De secondaire uitkomstmaten van deze studie zijn: 1) Verschillen in coherentie van hersenactiviteit in EEG signaal tussen kinderen die wel en niet klinisch responderen op methylfenidaat. 2) Verschillen in connectiviteit tussen het striatum/ IFG/SFG in resting state fMRI activiteit tussen kinderen die wel en niet klinisch responderen op methylfenidaat.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Children diagnosed with ADHD according to DSM IV criteria Age between 8-16 Willing to discontinue methylphenidate 48 hours before testing IQ above 75 |
Kinderen met de diagnose ADHD volgens DSM IV criteria leeftijd tussen 8-16 jaar Bereid om inname medicatie Methylfenidaat te staken 48 uur voor deelname onderzoek IQ score hoger dan 75 |
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E.4 | Principal exclusion criteria |
History of or present neurological disorder One or more of the following comorbid disorders are diagnosed: generalized anxiety disorder, depression, tics, psychosis or autism IQ below 75 |
Het lijden aan een neurologische stoornis, in verleden dan wel heden. Diagnose van een van de volgende stoornissen: gegeneraliseerde angst stoornis, depressie, tics, psychose of autisme IQ score onder 75. |
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E.5 End points |
E.5.1 | Primary end point(s) |
(1) Stop-associated ERP measures at baseline (N1 and P3) (2) Stop-associated fMRI measures at baseline (activitity in IFG an SFG) (3) DAT1 and COMT genotype
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(1) Stop-gerelateerde ERP meting als baseline (N1 en P3) (2) Stop-gerelateerde fMRI meting als baseline (activiteit in IFG en SFG) (3) genotypering voor DAT1 en COMT. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
After inclusion of enough participants to detect differences between responders and non-responders on at least one of the primary endpoints :estimated te be after inclusion of 80 subjects. |
Wanneer er genoeg deelnemers zijn geïncludeerd in de studie om een onderscheid te kunnen maken tussen responders en niet-responders, op ten minste een van de drie uitkomstmaten: dit ligt naar schatting op een aantal van 80 geïncludeerde deelnemers. |
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E.5.2 | Secondary end point(s) |
(1) Coherence of brain activity from EEG (2) Connectivity between IFG and SFG from RS-MRI
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(1) Coherentie van hersenactiviteit gemeten met EEG. (2) connectiviteit tussen de IFG en SFG gemetenmet RS-fMRI.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At same time as evaluation of primary endpoints.
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Tegelijk met de evaluatie van de primaire uitkomstmaten. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | Yes |
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
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LVLS |
Laatste bezoek laatste deelnemer. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |