| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN52376787 |
| Date ISRCTN assigned | 23/01/2004 |
| Local reference number(s) | RBP 98X24 |
| Public title | Working memory in children with attention-deficit/hyperactivity disorder (ADHD): the impact of methylphenidate (MPH). |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and behavioural disorders: Behavioural disorders |
| 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? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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. |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/09/1998 |
| Anticipated end date | 29/02/2000 |
| Status of trial | Completed |
| Target number of participants | 60 |
| Interventions | i. Methylphenidate (MPH) treatment
ii. No methylphenidate treatment |
| Primary outcome measure(s) | Provision of information about effects of MPH on cognitive function (including the possibility of cognitive toxicity) in children with ADHD; Provision of 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; Identification of potential cognitive deficits in ADHD. If persisting cognitive deficits are identified. These will be rational targets for supplementary treatment interventions; Suggestion of tests to monitor the effects of MPH on cognitive function which could be developed for use in everyday clinical practice. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | NHS Executive Trent |
| Sponsor name | NHS R&D Regional Programme Register - Department of Health (UK) |
| Sponsor details | The Department of Health
Richmond House
79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 (0)20 7307 2623 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.doh.gov.uk |
| Contact name | Dr Kim Cornish |
| Contact details | Developmental Psychiatry
Division of Psychiatry
E Floor, South Block
South Block
Queens Medical Centre
Nottingham
United Kingdom
NG7 2UH |
| Contact telephone | +44 (0)115 924 9924 |
| Contact fax | +44 (0)115 970 9946 |
| Contact email | kim.cornish@mcgill.ca |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN52376787 |
| Date last extracted from ISRCTN register | 17/04/2008 |
