The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD
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|ClinicalTrials.gov Identifier: NCT02501798|
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : May 13, 2016
|Condition or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Methylphenidate Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||61 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||May 2016|
Experimental: Drug: Methylphenidate
Drug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand)
Other Name: Equasym
Active Comparator: Drug: Placebo
Drug: Placebo 7 days Empty green-yellow capsule
Other Name: empty capsule
- Mathematical performance [ Time Frame: 3.5 years ]A standardized task for mathematics is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
- 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.
- Spelling performance [ Time Frame: 3.5 years ]A standardized task for spelling is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02501798
|Vrije Universiteit Amsterdam|
|Amsterdam, Netherlands, 1081BT|
|Principal Investigator:||Jaap Oosterlaan, Prof. Dr.||VU University of Amsterdam|