attention disorder Attention-Deficit/Hyperactivitiy Disorder
Conditions
Interventions
The participating subjects will be randomized (ratio 1:1) to either continued
use of methylphenidate or to placebo during seven weeks. Withdrawal will be
gradually over a period of three weeks, foll
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
2 Years to 17 Years
Inclusion criteria
Inclusion criteria: • Children between the ages of eight to eighteen, any ethnicity or cultural background. • Children with their first prescription of any form of methylphenidate at least two years ago. • Children who are for at least the last four weeks the subject has been using methylphenidate in the form of Concerta 36 mg or 54 mg. • Children with an IQ > 70 (based on a previous IQ test or attending regular education). • Parents (or the legal guardian) and children (>= twelve years) have provided informed consent to participate in the study.
Exclusion criteria
Exclusion criteria: • Children who have not been using of methylphenidate for a continuous period > 2 months during the last two years. • Children of parents who are planning to start new psychosocial or pharmacological therapies during the blinded period. • Children and or parents who are unable to understand or comply with the protocol. • Children who have any other significant disease or disorder which, in the opinion of the investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant*s ability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure will be the clinician based ADHD DSM-5 rating scale. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures: Rating scales • The Clinical Global Impression Scale of Improvement (CGI-I). • The criteria of Oppositional Defiant Disorder (ODD) • Side effects and withdrawal effects will be evaluated by an adapted version of the Barkley Side Effect Rating scale (BSERS). • The Sleep Disturbances Scale for Children (SDSC) • The appetite of the child • The Retrospective Overt Aggression Scale (R-MOAS) • The Kindl-R (quality of life) • The Parental Stress Scale (PSS) • Questions about family atmosphere questions • The Parental Frustrations Questionnaire (PFQ) • The Child Depression Inventory (CDI) • The Strength and Difficulties Questionnaire (SDQ). We will use the parent, teacher and self-report (ages 11-16) versions. • The Conners Teacher Rating Scale-Revised: short form (CTRS-R:S). Physical measures • Weight, height, blood pressure, pulse Biomarkers • Blood draw (ferritin, zinc and cholesterol) Neuropsychological tests • Amsterdam Neuropsychological Tasks (three subtests) • The Monetary incentive delay task for children Mediators/predictors • Treatment history, duration and compliance Child factors • Sex, age, ethnicity, school type • Estimation IQ • Psychiatric diagnoses • Tanner stage + some questions of Physical Development Scale (PDS) • Temperament (Behavioural Avoidance and Inhibition Scale [BISBAS], Inventory of Callous and Unemotional traits [ICU], Brief Sensation Seeking Scale [BSSS]) • DNA (blood draw) • Cortisol in hair • Stressful events Parental factors • Socio-economic factors • The Egna Minnen Beträffende Uppfostran (EMBU) • The Adult ADHD Rating scale (AARS) • The Parenting Sense of Competence Scale (PSOC) • The Maudsley Marital Questionnaire (MMQ)(subschale Marital adjustment) | — |
Countries
Netherlands
Outcome results
None listed