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Prediction of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate.


- candidate number2627
- NTR NumberNTR996
- ISRCTNISRCTN32841168
- Date ISRCTN created16-jul-2007
- date ISRCTN requested9-jul-2007
- Date Registered NTR13-jun-2007
- Secondary IDsP06-160C 
- Public TitlePrediction of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate.
- Scientific TitlePrediciton of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate.
- ACRONYMPrediciton of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate
- hypothesisThe 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).
- Healt Condition(s) or Problem(s) studiedADHD, Methylphenidate response, Electroencephalography (EEG), DNA, Theta/beta ratio
- Inclusion criteria1. Diagnosed with ADHD combined type (no primary diagnoses of attention deficit) according to DSM IV 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. 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.
- Exclusion criteria1. IQ is below 75;
2. One or more of the following comorbid disorders are diagnosed: anxiety disorder, depression, tics, psychosis or 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 (> 3 months).
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 25-mei-2007
- planned closingdate31-aug-2007
- Target number of participants50
- InterventionsMethylphenidate 10 mg.
- Primary outcomePrimary outcome measure is the absolute and relative power in different frequency bands of the EEG.
- Secondary outcomeEvent-related potentials in response to the stop-task and CPT, EEG coherence, Scores on the Spatial Span (SSP) task and Spatial Working Memory (SWM) task from the Cambridge Neuropsychological Test Automated Battery (CANTAB), gene polymorphisms of the dopamine D4 receptor (DRD4), dopamine transporter (DAT1), and serotonin transporter (5-HTT), scores on the SNAP-IV.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES A.E. Wester
- CONTACT for SCIENTIFIC QUERIES A.E. Wester
- Sponsor/Initiator Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Funding
(Source(s) of Monetary or Material Support)
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
- Publications
- Brief summaryApproximately 3 to 5 % of the children is diagnosed with ADHD. ADHD is mostly treated with methylphenidate. However 30 % of the children with ADHD does not respond to methylphenidate. At this moment there is no objective tool available to predict methylphenidate response. It would be of great value to have an objective tool. EEG power measures, ERPs, neuropsychological tests, and DNA all seem to have some predictive value with regard to methylphenidate response. The aim of the present study is to investigate the predictive value of EEG power by studying EEG power differences between responders and non-responders to methylphenidate. Furthermore, the predictive value of EEG power measures will be compared with the predictive value of DNA, neuropsychological tests and ERPs. Brain activity, DNA, and task performance (stop-task, CPT, Spatial Span task, Spatial Working Memory Task) will be measured in methylphenidate-naive patients in a baseline condition and after treatment administration (10 mg methylphenidate).
- Main changes (audit trail)
- RECORD13-jun-2007 - 9-dec-2009


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