Condition category
Mental and Behavioural Disorders
Date applied
16/07/2007
Date assigned
16/07/2007
Last edited
16/07/2007
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 A.E. Wester

ORCID ID

Contact details

Utrecht Institute for Pharmaceutical Sciences
Utrecht University
Utrecht
3584 CA
Netherlands
+31(0)30 253 7768
A.E.Wester@uu.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P06-160C

Study information

Scientific title

Acronym

Study hypothesis

The EEG profile in responders to methylphenidate will be differ from the EEG profile in non-responders to methylphenidate (i.e., higher total power, increased theta/beta ratio and theta/alpha ratio).

Ethics approval

Ethics approval received from the local medical ethics committee

Study design

Clinical trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

Hospitals

Trial type

Not Specified

Patient information sheet

Condition

Medication response in children with Attention Deficit Hyperactivity Disorder (ADHD)

Intervention

Methylphenidate 10 mg.

Intervention type

Drug

Phase

Not Specified

Drug names

Methylphenidate

Primary outcome measures

Primary outcome measure is the absolute and relative power in different frequency bands of the EEG.

Secondary outcome measures

1. Event-related potentials in response to the stop-task and Continuous Performance Test (CPT)
2. EEG coherence
3. Scores on the Spatial Span (SSP) task and Spatial Working Memory (SWM) task from the Cambridge Neuropsychological Test Automated Battery (CANTAB)
4. Gene polymorphisms of the dopamine D4 receptor (DRD4), dopamine transporter (DAT1), and serotonin transporter (5-HTT)
5. Scores on the 18-item Swanson, Nolan and Pelham Teacher and Parent Rating Scale (SNAP-IV)

Overall trial start date

25/05/2007

Overall trial end date

31/08/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosed with ADHD combined type (no primary diagnoses of attention deficit) according to Diagnostic and Statistic Manual of mental disorders - fourth edition - criteria (DSM IV, APA 1994)
2. They have (no history of) anxiety disorder, depression, tics, psychosis or autism
3. Their age is ranged between 7 and 12
4. Intelligence Quotient (IQ) is above 75
5. They are free from psychoactive medication
6. They are free from methylphenidate at least 48 hours before testing
7. They have no known cardiovascular disease
8. Normal static binocular acuity, corrected or uncorrected
9. Written informed consent from the parents

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

50

Participant exclusion criteria

1. IQ is below 75
2. One or more of the following co-morbid disorders are diagnosed:
2.1. Anxiety disorder
2.2. Depression
2.3. Tics
2.4. Psychosis
2.5. Autism
3. Prior enrolment in the same study
4. Participation in another clinical trial simultaneously
5. Familiar with epileptic disorders
6. Long term usage of methylphenidate (greater than three months)

Recruitment start date

25/05/2007

Recruitment end date

31/08/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Utrecht Institute for Pharmaceutical Sciences
Utrecht
3584 CA
Netherlands

Sponsor information

Organisation

Utrecht Institute for Pharmaceutical Sciences (The Netherlands)

Sponsor details

Utrecht University
P.O. Box 80082
Utrecht
3508 TB
Netherlands

Sponsor type

Research organisation

Website

http://www.pharm.uu.nl/ffwuk.htm?/uips/

Funders

Funder type

Research organisation

Funder name

Utrecht Institute for Pharmaceutical Sciences (The Netherlands)

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