ADHD
Conditions
Interventions
This study is a Randomized Controlled Trial (RCT) with two treatment conditions for titration of MPH. A total of 140 children with DSM-V ADHD diagnosis and indication for pharmacological treatment wit
n = 70) and II) stepwise titration group (n = 70).
Sponsors
Innovatiefonds Zorgverzekeraar
Eligibility
Inclusion criteria
Inclusion criteria: 1. ADHD diagnosis according to the DSM-V criteria (all subtypes), by a therapist; 2. Indication for treatment with short-acting MPH; 3. Age between 6 and 12 years; 4. Attending (any type of) primary school; 5. Parents and teachers master the Dutch language to such a degree that they may read and understand the questionnaires that need to be filled out as part of the study.
Exclusion criteria
Exclusion criteria: 1. Contra-indication for MPH such as described in the Farmacotherapeutisch Kompas. For example, MPH can be contraindicated in patients with Gilles de la Tourette, cardiovascular problems, cerebrovascular problems or bipolar disorder or use of MAO inhibitors, Cobicistat and Ritonavir. 2. Treated with MPH in the last 4 weeks. Some questionnaires that are used in the baseline assessment require evaluation over the 6 months prior to filling out the questionnaire. When there has been MPH use in the last 6 months parents, teachers and practitioners will be asked to complete the questionnaire based on the behavior in the period without MPH use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main study outcomes are: I.The number of children with nonresponses, placebo responses and insufficient clinical responses: evaluated with the follow up questionnaire. II.The number and severity of remaining ADHD and ODD behaviours, side effects, comorbidities (for example: internalising disorders) and social skills scores: evaluated with SWAN, side effect rating scale, Disruptive Behavior Rating Scale, CBCL, TRF and SSRS. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcome measures are: III. The duration of the titration period before the maintenance dose is reached and the number of patient-therapist contacts: evaluated with the Follow up questionnaire. IV. Childrens,’ parents’, teachers’ and therapists’ satisfaction about the titration (including opinion towards the titration method and medication advice based on the application): evaluated with the Follow up questionnaire. V. Possible predictors for (non-)responders (for example: estimated IQ, socio-demographic parameters, comorbid disorders, number and severity of ADHD symptoms): evaluated with all questionnaires in 7.1 , K-SADS interview and estimated IQ. | — |
Contacts
Public ContactKaren Vertessen
Vrije Universiteit Amsterdam
Outcome results
None listed