Clinical trial NCT02501798: The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD
Official title: The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
Methylphenidate
Academic
Motivation
Lead sponsor: VU University of Amsterdam
Sponsor class: OTHER
Collaborators: name: Shire
First posted: 2015-07-17
Enrollment: 61
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study aims at investigating the direct effects of methylphenidate on school performance of primary school children. Although behavioral effects of this frequently prescribed drug are thoroughly studied (and confirmed), the effects of methylphenidate on school performance are less clear. Recent overviews indicate that effects are mainly quantitative and subject-specific. To gain more insight in this issue, the current double blind placebo controlled crossover study investigates not only the effects of methylphenidate on school performance but also it's effect on related variables such as short term memory, motivation and behavior. 60 children with ADHD are included and tested twice (with medication and with placebo) at their primary school.

Detailed description: Rationale: ADHD (attention deficit hyperactivity disorder) is a common childhood developmental disorder. Besides the behavioural symptoms of ADHD, many children with ADHD experience problems with academic activities. More specifically, these children show problems with math, spelling and reading. The most common treatment for ADHD is medical treatment with methylphenidate (MPH). This treatment is effective in the reduction of ADHD symptoms. However, it is unclear whether treatment with MPH can also improve academic activity. If MPH improves academic activity, it is of great interest to understand which variables influence or mediate this effect. The results from this study can give more insight in the working mechanisms and effectiveness of MPH in reducing the academic problems commonly observed in children with ADHD.

Objectives: The main objective of this study is to assess the impact of MPH on academic activity and to estimate the role of three putative mediators in this relation.

Study design and population: This study is a randomised, double-blind, placebo-controlled cross-over design with a patient group and a control group. Main study parameters/endpoints: The main study parameters are changes in academic activity (ability, effort and engagement). In addition, changes in putative mediators are assessed.

Eligibility criteria: Inclusion Criteria:

* ADHD diagnosis (DSM-IV)
* primary school education
* sufficient knowledge of Dutch language

Exclusion Criteria:

* neurological or psychiatric disorder other than ODD, CD, learning disorder, dyslexia, anxiety disorder

Healthy volunteers are accepted for the control group

Primary outcomes:
measure: Mathematical performance
timeFrame: 3.5 years
measure: Reading performance
timeFrame: 3.5 years
measure: Spelling performance
timeFrame: 3.5 years
Secondary outcomes:
measure: Cognitive performance
timeFrame: 3.5 years
measure: Academic motivation
timeFrame: 3.5 years
measure: Classroom behavior
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: Vrije Universiteit Amsterdam
Study officials:
affiliation: VU University of Amsterdam
name: Jaap Oosterlaan, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: