Condition category
Mental and Behavioural Disorders
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
14/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.doh.gov.uk

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

Publication citations

Additional files

Editorial Notes

14/03/2016: No publications found, verifying study status with principal investigator