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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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10064104 |
E.1.2 | Term | ADHD |
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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 |
To examine the modulation of the functional brain activity during working memory processes by therapeutic methylphenidate administration in ADHD patients, in interaction with the COMT Val158Met genotype. |
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E.2.2 | Secondary objectives of the trial |
To examine the clinical improvement of ADHD symptoms and general functioning by therapeutic methylphenidate administration in ADHD patients, in interaction with the COMT Val158Met genotype. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Only participants will be included who (1) fulfil the diagnostic criteria defined in guidelines for the diagnosis of ADHD in childhood and adulthood and who (2) would be treated with MPH also for clinical indications outside the study. 2. Provision of written informed consent 3. A diagnosis of a ADHD (314.xx) by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV) 4. Females and males aged 18-50 years 5. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment 6. Able to understand and comply with the requirements of the study 7. Right-handed according Edinburgh Handedness Inventory (Oldfield, 1971) 8. German as first language 9. Caucasian ethnicity
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E.4 | Principal exclusion criteria |
1. Pregnancy or lactation; women capable of childbearing are required to use a reliable method (Pearl-index < 1%) of contraception (e.g. hormonal treatment, intrauterine device, vasoligature in the partner, sexual abstinent) 2. Any current DSM-IV Axis I disorder not defined in the inclusion criteria requiring current additional treatment 3. Motoric tics, siblings with tics or positive family history or diagnosis of a Tourette syndrome 4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 5. Known intolerance or lack of response to methylphenidate, as judged by the investigator 6. Present pre-treatment with methylphenidate within the last 3 month prior to study treatment 7. Intake of MAO-inhibitors within the last 14 days prior to of study treatment 8. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 9. Unstable or inadequately treated medical illness (e.g. Congestive Heart Failure / CHF, angina pectoris, hypertension, narrow angle glaucoma, hyperthyreoidism, thyreotoxicosis, cardiac arrhythmia, cardiac infarction) as judged by the investigator. 10. Epilepsy 11. An absolute neutrophil count (ANC) of 1.5 x 109 per litre 12. Involvement in the planning and conduct of the study 13. Previous enrolment or randomisation of treatment in the present study 14. Participation in another drug trial within 4 weeks prior to enrolment into this study or longer in accordance with local requirements 15. Moderate, severe, or profound mental retardation 16. Heart pacemakers, cochlea implants, other metal parts in the head outside the mouth
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E.5 End points |
E.5.1 | Primary end point(s) |
fMRI measurement at day 42 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | Yes |
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 | Yes |
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 | Information not present in EudraCT |
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 last subject |
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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 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |