Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Interventions
Trade Name: Medikinet 10 mg, tabletten
Product Name: Medikinet
Product Code: 381543
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral
Sponsors
Accare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Children between the ages 6 and 12, any ethnicity or cultural background • Who have been diagnosed with ADHD as confirmed with the Parent Interview for Child Symptoms (PICS) (obtained during routine clinical assessment) • Who are going to start methylphenidate as per clinical decision • No use of methylphenidate for the past six months • Have a bodyweight of at least 20 kilograms • Deemed reliable and compliant with the protocol • Parents (or the legal guardian) and children (twelve years) have provided informed consent to participate in the study. Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) no 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: • Intellectual disability (based on available IQ below 70 or the clinical opinion of the investigator, taking into account relevant psychosocial information, e.g. educational level/academic achievements; or as confirmed by the IDS-2 IQ screener obtained in each participant, see section 7.1.2)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Our overall objective is to investigate the acute effects of a single dosage of methylphenidate on behavior in the classroom and on cognitive functioning. By means of randomized, double-blind, placebo-controlled cross-over trials, we will test the hypothesis that after nine months of treatment with methylphenidate, the effects on classroom behavior, the performance on a neuropsychological test battery, and brain activity diminishes, compared to the acute effects of methylphenidate in drug naïve children. ;Secondary Objective: To investigate the association between performance on neuropsychological tasks, brain activity, and classroom behavior.;Primary end point(s): A significant better performance on the neuropsychological tasks, normalisation of brain activity and reduction of ADHD-related behaviour in the classroom after administration of methylphenidate compared to placebo. ;Timepoint(s) of evaluation of this end point: There will be a comparison between methylphenidate and placebo in drug-naïve children (week 1 and 2) and after nine months of treatment (week 39 and 40). | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Not applicable as the secondary objectives are aimed at investigating the relationship between variables.;Timepoint(s) of evaluation of this end point: The relationship will be assessed after week 2 and after week 40. | — |
Countries
Netherlands
Contacts
Public ContactAndrea Dietrich
Accare
Outcome results
None listed