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Completed

NCT Number: NCT02501798

The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vrije Universiteit Amsterdam

Amsterdam, 1081BT, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Drug: Methylphenidate

Other names: Equasym

Placebo

Drug

Drug: Placebo

Other names: empty capsule

Primary outcomes

  1. Mathematical performance

    Time frame: 3.5 years

    A standardized task for mathematics is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.

  2. Reading performance

    Time frame: 3.5 years

    A standardized task for technical reading ability is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.

  3. Spelling performance

    Time frame: 3.5 years

    A standardized task for spelling is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.

Secondary outcomes

  1. Cognitive performance

    Time frame: 3.5 years

    Cognitive performance will be measured with standardized tasks for interference control, verbal and spatial working memory. Using principal component analysis a combined (composite) score for cognitive performance will be calculated based on correlations between the measures.

  2. Academic motivation

    Time frame: 3.5 years

    Academic motivation will be measured with a questionnaire measuring intrinsic motivation for schoolwork. In addition, an academic competence questionnaire will be completed by children, parents and teachers separately. A composite score will be calculated of these measures.

  3. Classroom behavior

    Time frame: 3.5 years

    Classroom behavior will be measured with observation scales (by an independent observer) and behavioral rating scales (completed by teachers). Using principal component analysis, these scales will be combined (composite scores), depending on correlations between the measures.

Sponsors and collaborators

Lead sponsor

VU University of Amsterdam

Other

Collaborators

  • Shire

Registry information

Official study title

The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Jul 17, 2015
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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