Attention Deficit Hyperactivity Disorder (ADHD)
Conditions
Interventions
Four day use of methylphenidate in a regular dose and four days use of placebo
Sponsors
Accare
Eligibility
Age
2 Years to 17 Years
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.
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 |
|---|---|
| Measures include observations of classroom behavior rated by trained investigators and as perceived by the teacher (e.g. hyperactivity, off-task behavior, disobedient behavior, and (verbal) aggression), as well as the performance on the neuropsychological test battery measuring spatial working memory, sustained attention, response inhibition, and motor and mental response speed. Furthermore, EEG measures during rest (i.e. theta and beta power, theta/beta ratio) and during a response inhibition task (P300 peak) will be analyzed. | — |
Secondary
| Measure | Time frame |
|---|---|
| Physical activity during classroom observation and everyday cognitief functioning as rated by the parents (BRIEF-P). | — |
Countries
Netherlands
Outcome results
None listed