| - candidate number | 2627 |
| - NTR Number | NTR996 |
| - ISRCTN | ISRCTN32841168 |
| - Date ISRCTN created | 16-jul-2007 |
| - date ISRCTN requested | 9-jul-2007 |
| - Date Registered NTR | 13-jun-2007 |
| - Secondary IDs | P06-160C |
| - Public Title | Prediction of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate. |
| - Scientific Title | Prediciton of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate. |
| - ACRONYM | Prediciton of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate |
| - 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). |
| - Healt Condition(s) or Problem(s) studied | ADHD, Methylphenidate response, Electroencephalography (EEG), DNA, Theta/beta ratio |
| - Inclusion criteria | 1. 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 criteria | 1. 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 received | yes |
| - multicenter trial | no |
| - randomised | no |
| - group | [default] |
| - Type | Single arm |
| - Studytype | intervention |
| - planned startdate | 25-mei-2007 |
| - planned closingdate | 31-aug-2007 |
| - Target number of participants | 50 |
| - Interventions | Methylphenidate 10 mg. |
| - Primary outcome | Primary outcome measure is the absolute and relative power in different frequency bands of the EEG. |
| - Secondary outcome | Event-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. |
| - Timepoints | N/A |
| - Trial web site | N/A |
| - status | inclusion 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 summary | Approximately 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) | |
| - RECORD | 13-jun-2007 - 9-dec-2009 |
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