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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02501798
• Other study ID #: VU-2012-000492-17
• Status: Completed
• Phase: Phase 4
• First received: April 9, 2014
• Last updated: May 12, 2016
• Start date: January 2013
• Est. completion date: May 2016

Study information

• Verified date: May 2016
• Source: VU University of Amsterdam
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: May 2016
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 12 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder

Intervention

Drug:
• Methylphenidate
Drug: Methylphenidate
• Placebo
Drug: Placebo

Locations

Country	Name	City	State
Netherlands	Vrije Universiteit Amsterdam	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
VU University of Amsterdam	Shire

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mathematical performance	A standardized task for mathematics is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.	3.5 years	No
Primary	Reading performance	A standardized task for technical reading ability is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.	3.5 years	No
Primary	Spelling performance	A standardized task for spelling is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.	3.5 years	No
Secondary	Cognitive performance	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.	3.5 years	No
Secondary	Academic motivation	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.	3.5 years	No
Secondary	Classroom behavior	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.	3.5 years	No