Attention Deficit Hyperactivity Disorder
Conditions
Interventions
Product Name: Methylphenidate HCL
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Innovatiefonds Zorgverzekeraars
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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. Are the trial subjects under 18? yes Number of subjects for this age range: 160 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: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1.Counter-indication for the start-up of MPH. For example, MPH can be contraindicated in patients with Gilles de la Tourette, cardiac problems, or bipolar disorder. 2.Treated with MPH in the last 6 months, in order to be able to evaluate the children's behavior over a period without medication at baseline (the start of the RCT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary purpose of this study is to investigate whether Placebo Controlled Titration (PCT) leads to an optimization of the use of MPH in clinical practice. The hypotheses are that: 1.PCT is more sensitive in detecting placebo- and non-responders compared to stepwise titration. Therefore, the number of placebo- and non-responders that are detected will be higher in the PCT group; 2.PCT leads to a more optimal dose, with better ADHD and ODD symptom reduction and less side effects, compared to stepwise titration; 3.The maintenance dose is reached faster and with less pharmacological changes in the PCT group compared to stepwise titration. ;Secondary Objective: Secondary Objectives The second objective of this research is to develop a user-friendly titration method that will help therapists to make objective decisions about titration. We expect that: 4. Parents’, teachers’ and therapists’ satisfaction about titration is higher in PCT compared to stepwise titration;Timepoint(s) of evaluation of this end point: Subjects wille be evalueted for primary end points at baseline 9T), after 8 weeks (T2) and after 6 months (T3).;Primary end point(s): Primary study parameter(s) The main hypotheses tested in this study are: 1.The number of placebo- and non-responders that are detected will be higher in the PCT group. The main outcome measure to test this hypothesis is the proportion of children who continue MPH treatment after titration, measured both at T2 and T3, for each treatment condition. The proportion of children who continue treatment is determined by the number of children who are still being prescribed MPH at T2 or T3, divided by the total number of children who entered the trial in the respective treatment condition. Secondary analyses will evaluate whether the proportion of placebo- and non-responders is similar to previously reported numbers (e.g. by the MTA-study) by calculating the proportion of placebo- and non-responders within the PCT group | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary hypothesis tested in this study is that satisfaction with the titration method will be higher for PCT compared with stepwise titration for parents, teachers and therapists. For all informants, an aggregate score for satisfaction will be composed based on the satisfaction questionnaire. This score will be compared between the two treatment groups at T2 and T3. Additionally, results of the satisfaction questionnaires will be evaluated in a qualitative manner. Concerns and suggestions raised by parents, teachers and therapists will be discussed in the research team in order to optimize the use of PCT in clinical practice;Timepoint(s) of evaluation of this end point: Subjects wille be evalueted for secondary end points at baseline 9T), after 8 weeks (T2) and after 6 months (T3) | — |
Countries
Netherlands
Contacts
Public ContactKaren Vertessen
VU University Amsterdam Faculty of Behavioural and Movement Sciences Section Clinical Neorlopsychology
Outcome results
None listed