healthy volunteers
Conditions
Interventions
Trade Name: Methylphenidat Hexal 10 mg tablets
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Methylphenidate
CAS Number: 19262-68-1
Other descriptive name: DEXMETHYLPHENIDATE HYDROCHLORIDE
Sponsors
Charité Universitaetsmedizin Berlin
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: - Men - 18 - 35th age - Written consent (according to AMG § 40 (1) 3b) - Good knowledge of German - right-handedness 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 48 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Known hypersensitivity to the investigational medicinal product or a chemically similar substance or any of the components of the investigational - All contraindications to study drug (as excipients of the dosage form): cardiac arrhythmia, hyperthyroidism, glaucoma, pheochromocytoma, heart failure, diabetes mellitus, known liver and kidney dysfunction, vascular disease, angina, haemodynamically significant, congenital heart disease, cardiomyopathy, myocardial infarction, channelopathies arterial hypertension, pre-cerebrovascular diseases, such as cerebral aneurysms, vascular abnormalities including vasculitis or stroke. - Participation in other clinical trials during or within one month prior to this clinical trial - Medical or psychological conditions that can compromise the proper conduct of the trial - Existing serious somatic illnesses, even if these are not covered by the contraindications according to the specialist information - Existing psychiatric disorders and psychiatric disorders in the prehistory - Smokers or ex-smokers for less than 5 years - Regular caffeine consumption> 4 cups per day - Subjects with irregular circadian rhythm (eg shift workers) - Unwillingness to the storage and disclosure of pseudonymous data as part of the clinical trial - Placing in an institution for a court or administrative order (according to AMG § 40 (1) 4) - MR contraindications (eg pacemakers, metallic or electronic implants, metal fragments, tinnitus, surgical clips)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Resting state parameters from functional magnetic resonance imaging (fMRI). These include the so-called Reho (regional homogeneity) and ALFF (amplitude of low frequency fluctuation);Secondary Objective: Performance in neuropsychological testing and the number of self-reported side effects;Primary end point(s): ReHo (regional homogeneity) und ALFF (amplitude of low frequency fluctuation) in functional magnetic resonance imaging (fMRI);Timepoint(s) of evaluation of this end point: 2-4 hours after medication or placebo intake | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Performance in neuropsychological testing and the number of self-reported side effects;Timepoint(s) of evaluation of this end point: 2-4 hours after medication or placebo intake | — |
Countries
Germany
Contacts
Public ContactDr. Dimitris Repantis
Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charitè-Universitätsmedizin, CBF
Outcome results
None listed