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

NCT02501798 | Completed Phase 4

• 1 other identifier: VU-2012-000492-17
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD; Methylphenidate; Academic; Motivation

Outcome Measures

Primary Outcomes (3)

• Mathematical performance

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

  3.5 years

• Reading performance

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

  3.5 years

• Spelling performance

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

  3.5 years

Secondary Outcomes (3)

• Cognitive performance

  3.5 years

• Academic motivation

  3.5 years

• Classroom behavior

  3.5 years

Study Arms (2)

Drug: Methylphenidate

EXPERIMENTAL

Drug: Methylphenidate 7 days dosage as (prior to study) clinically titrated long acting Equasym (brand)

Drug: Methylphenidate

Drug: Placebo

ACTIVE COMPARATOR

Drug: Placebo 7 days Empty green-yellow capsule

Drug: Placebo

Interventions

Methylphenidate DRUG

Drug: Methylphenidate

Also known as: Equasym

Drug: Methylphenidate

Placebo DRUG

Drug: Placebo

Also known as: empty capsule

Drug: Placebo

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• ADHD diagnosis (DSM-IV)
• primary school education
• sufficient knowledge of Dutch language

You may not qualify if:

• neurological or psychiatric disorder other than ODD, CD, learning disorder, dyslexia, anxiety disorder
• Healthy volunteers are accepted for the control group

Sponsors & Collaborators

• VU University of Amsterdam: lead
• Shire: collaborator

Study Sites (1)

Vrije Universiteit Amsterdam

Amsterdam, 1081BT, Netherlands

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jaap Oosterlaan, Prof. Dr.

  VU University of Amsterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: A.F. Kortekaas-Rijlaarsdam

Study Record Dates

• First Submitted: April 9, 2014
• First Posted: July 17, 2015
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: May 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

NL (1)