E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Attention-deficit hyperactivity disorder (ADHD) |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Psychiatry and Psychology [F] - Mental Disorders [F03] |
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 primary objective of this study is to explore the relationship between MPH and academic activity and the mediating roles of ADHD behaviours, cognitive deficits and motivational deficits in this relationship. Therefore, the direct effects of MPH on ADHD behaviours, cognitive deficits and motivational deficits are taken into account. In particular, evidence on the effects of MPH on motivational deficits in ADHD is scarce. It is hypothesized that treatment with MPH results in increased academic activity as compared to placebo control. If MPH improves academic activity, comparisons with the control group will be made to see if academic activity in children with ADHD normalises when treated with MPH. |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives are to explore the relation between academic effort and engagement and academic ability, resulting in a clearer description of the construct of academic activity which is a frequently used outcome variable in many clinical studies. Furthermore, the relation between behaviour, cognition, motivation and academic activity will be studied in children between 8-13 years old. A comparison between children with ADHD and healthy controls will be made to investigate whether the relationship between these variables differs between these groups. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
i. Diagnosis of AD(H)D according to DSM-IV or ICD-10 ii. Current treatment or to-be initiated treatment with methylphenidate to reduce ADHD symptoms iii. Age between 8 and 13 years iv. IQ above 70 v. Sufficient knowledge of the Dutch language (child and parent/caregiver)
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E.4 | Principal exclusion criteria |
i. Psychiatric disorder other than ADHD, oppositional defiant disorder, conduct disorder, anxiety disorder or learning disorder ii. Neurological impairment iii. Medication other than methylphenidate
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvements in academic effort and engagement, improvements in academic abilities (math, spelling and reading), decreased ADHD behaviours, reduced cognitive and motivational deficits |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
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 | 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
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Last visit of the last participant |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |