|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
Netherlands Trial Register |
|
Last refreshed on:
|
28 April 2013 |
|
Main ID: |
NTR996 |
|
Date of registration:
|
13/06/2007 |
|
Primary sponsor: |
|
|
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. - Prediciton of medication response in children with ADHD: EEG differences between responders and non-responders to methylphenidate |
|
Date of first enrolment:
|
25/5/2007 |
|
Target sample size:
|
50 |
|
Recruitment status: |
complete |
|
URL:
|
http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=996 |
|
Study type:
|
intervention |
|
Study design:
|
Randomised: No; Masking: None; Control: Not applicable; Group: [default]; Type: Single arm
|
|
|
Countries of recruitment
|
|
The Netherlands
| | | | | | | |
|
Contacts
|
|
Name:
|
A.E.
Wester |
|
Address:
|
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Sorbonnelaan 16
3584 CA
Utrecht
The Netherlands |
|
Telephone:
|
+31(0)302537768 |
|
Email:
|
A.E.Wester@uu.nl |
|
Affiliation:
|
|
|
|
Name:
|
A.E.
Wester |
|
Address:
|
Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Sorbonnelaan 16
3584 CA
Utrecht
The Netherlands |
|
Telephone:
|
+31(0)302537768 |
|
Email:
|
A.E.Wester@uu.nl |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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).
Age minimum:
Age maximum:
Gender:
|
|
Health Condition(s) or Problem(s) studied
|
ADHD, Methylphenidate response, Electroencephalography (EEG), DNA, Theta/beta ratio
|
|
Intervention(s)
|
|
Methylphenidate 10 mg.
|
|
Primary Outcome(s)
|
|
Primary outcome measure is the absolute and relative power in different frequency bands of the EEG.
|
|
Secondary Outcome(s)
|
|
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.
|
|
Secondary ID(s)
|
|
ISRCTN32841168
|
|
P06-160C
|
|
Source(s) of Monetary Support
|
|
Utrecht Institute for Pharmaceutical Sciences, Utrecht University
|
|