Attention-deficit hyperactivity disorder (ADHD) MedDRA version: 9.1 Level: LLT Classification code 10064104 Term: ADHD
Conditions
Interventions
Trade Name: Medikinet
Pharmaceutical Form: Tablet
INN or Proposed INN: Methylphenidat-HCL
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceutical form o
Sponsors
Universitätsklinikum Würzburg
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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.;Primary end point(s): fMRI measurement at day 42 | — |
Countries
Germany
Outcome results
None listed