Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 19 of 439 for:    Methylphenidate

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02501798
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : May 13, 2016
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Anne Fleur Kortekaas-Rijlaarsdam, VU University of Amsterdam

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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Drug: Placebo Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Drug: Methylphenidate
Drug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand)
Drug: Methylphenidate
Drug: Methylphenidate
Other Name: Equasym

Active Comparator: Drug: Placebo
Drug: Placebo 7 days Empty green-yellow capsule
Drug: Placebo
Drug: Placebo
Other Name: empty capsule




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

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


Locations
Layout table for location information
Netherlands
Vrije Universiteit Amsterdam
Amsterdam, Netherlands, 1081BT
Sponsors and Collaborators
VU University of Amsterdam
Shire
Investigators
Layout table for investigator information
Principal Investigator: Jaap Oosterlaan, Prof. Dr. VU University of Amsterdam

Additional Information:
Layout table for additonal information
Responsible Party: Anne Fleur Kortekaas-Rijlaarsdam, A.F. Kortekaas-Rijlaarsdam, VU University of Amsterdam
ClinicalTrials.gov Identifier: NCT02501798     History of Changes
Other Study ID Numbers: VU-2012-000492-17
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Keywords provided by Anne Fleur Kortekaas-Rijlaarsdam, VU University of Amsterdam:
ADHD
Methylphenidate
Academic
Motivation
Additional relevant MeSH terms:
Layout table for MeSH terms
Methylphenidate
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents