Attention Deficit Hyperactivity DisorderPhase 4NCT02501798
The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by VU University of Amsterdam at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2013to May 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- ADHD diagnosis (DSM-IV)
- primary school education
- sufficient knowledge of Dutch language
Who cannot join
- neurological or psychiatric disorder other than ODD, CD, learning disorder, dyslexia, anxiety disorder
- Healthy volunteers are accepted for the control group
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial
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.
Read the 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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate, Placebo
- Keywords
- ADHD, Methylphenidate, Academic, Motivation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethylphenidateDrug
Also called Equasym
Drug: Methylphenidate
PlaceboDrug
Also called empty capsule
Drug: Placebo
| Study group | Role | What they receive |
|---|---|---|
| Drug: Methylphenidate | Experimental | Drug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand) Receives: Drug: Methylphenidate |
| Drug: Placebo | Active comparator | Drug: Placebo 7 days Empty green-yellow capsule Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mathematical performance
A standardized task for mathematics is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
Measured: 3.5 years
Reading performance
A standardized task for technical reading ability is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
Measured: 3.5 years
Spelling performance
A standardized task for spelling is used. Productivity (% completed) and accuracy (%correct) will be calculated for analysis.
Measured: 3.5 years
Secondary outcomes (3)
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.
Measured: 3.5 years
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.
Measured: 3.5 years
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.
Measured: 3.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VU University of Amsterdam
- Sponsor type
- University, hospital or other
- Collaborators
- Shire
- Responsible party
- Principal investigator, Anne Fleur Kortekaas-Rijlaarsdam, VU University of Amsterdam
- Investigators
- Jaap Oosterlaan, Prof. Dr., Principal investigator, VU University of Amsterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02501798
- Sponsor's protocol ID
- VU-2012-000492-17
- Status last verified
- May 2016
- First submitted
- 9 Apr 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Long-acting Methylphenidate on Academic Activity and Related Constructs in Children With ADHD: A Randomised Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT02501798
- Acronym / sponsor ID
- VU-2012-000492-17
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD, Methylphenidate, Academic, Motivation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (estimated)
- Lead sponsor
- VU University of AmsterdamUniversity, hospital or other
- Collaborators
- Shire
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 17 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug: Methylphenidate | Experimental | Drug: MethylphenidateDrug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand) |
| Drug: Placebo | Active comparator | Drug: PlaceboDrug: Placebo 7 days Empty green-yellow capsule |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ADHD diagnosis (DSM-IV)
- primary school education
- sufficient knowledge of Dutch language
Key exclusion criteria (2 listed)
- neurological or psychiatric disorder other than ODD, CD, learning disorder, dyslexia, anxiety disorder
- Healthy volunteers are accepted for the control group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylphenidateAlso: EquasymDrug: Methylphenidate | Drug | Drug: Methylphenidate |
| PlaceboAlso: empty capsuleDrug: Placebo | Drug | Drug: Placebo |
Primary outcome
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.
3 secondary outcomes
Cognitive performance
Time frame: 3.5 years
Academic motivation
Time frame: 3.5 years
Classroom behavior
Time frame: 3.5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaap Oosterlaan, Prof. Dr. principal investigator
VU University of Amsterdam
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by VU University of Amsterdam at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mathematical performance (time frame: 3.5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.