Contact information
Type
Scientific
Primary contact
Dr Kim Cornish
ORCID ID
Contact details
Developmental Psychiatry
Division of Psychiatry
E Floor
South Block
South Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924
kim.cornish@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RBP 98X24
Study information
Scientific title
Working memory in children with attention-deficit/hyperactivity disorder (ADHD): the impact of methylphenidate (MPH)
Acronym
Study hypothesis
To address the following questions: What are the effects of methylphenidate on working memory in children with ADHD? Is there evidence for differential effects of MPH on working memory function? What is the relationship between the effects of MPH on working memory, behavioural inhibition, non-executive memory performance and hyperactive/impulsive behaviour?
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Behavioural disorders
Intervention
1. Methylphenidate (MPH) treatment
2. No methylphenidate treatment
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
1. Information about effects of MPH on cognitive function (including the possibility of cognitive toxicity) in children with ADHD
2. Greater understanding of the underlying cognitive processes in ADHD
This knowledge of underlying mechanisms will lead to improved specificity of early detection, diagnosis and treatment of ADHD
3. Identification of potential cognitive deficits in ADHD. If persisting cognitive deficits are identified. These will be rational targets for supplementary treatment interventions
4. Suggestion of tests to monitor the effects of MPH on cognitive function which could be developed for use in everyday clinical practice.
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1998
Overall trial end date
29/02/2000
Reason abandoned
Eligibility
Participant inclusion criteria
60 boys aged between 7-12 years, receiving MPH, with a diagnosis of Hyperkinetic disorder or the equivalent ADHD combined sub-type, will be recruited from out-patient psychiatric clinics in the Trent region.
Participant type
Patient
Age group
Child
Gender
Male
Target number of participants
60
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/09/1998
Recruitment end date
29/02/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
NHS Executive Trent (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary