Prediction of medication response in children with Attention Deficit Hyperactivity Disorder (ADHD): Electroencephalogram (EEG) differences between responders and non-responders to methylphenidate
| ISRCTN | ISRCTN32841168 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN32841168 |
| ClinicalTrials.gov (NCT) | Nil Known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | P06-160C, NL969 (NTR996) |
| Sponsor | Utrecht Institute for Pharmaceutical Sciences (The Netherlands) |
| Funder | Utrecht Institute for Pharmaceutical Sciences (The Netherlands) |
- Submission date
- 16/07/2007
- Registration date
- 16/07/2007
- Last edited
- 27/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Utrecht Institute for Pharmaceutical Sciences
Utrecht University
Utrecht
3584 CA
Netherlands
| Phone | +31(0)30 253 7768 |
|---|---|
| A.E.Wester@uu.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Clinical trial |
| Secondary study design | Single-centre |
| Scientific title | Prediction of medication response in children with Attention Deficit Hyperactivity Disorder (ADHD): Electroencephalogram (EEG) differences between responders and non-responders to methylphenidate |
| Study objectives | 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(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Medication response in children with Attention Deficit Hyperactivity Disorder (ADHD) |
| Intervention | Methylphenidate 10 mg. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Methylphenidate |
| Primary outcome measure(s) |
Primary outcome measure is the absolute and relative power in different frequency bands of the EEG. |
| Key secondary outcome measure(s) |
1. Event-related potentials in response to the stop-task and Continuous Performance Test (CPT) |
| Completion date | 31/08/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 7 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Target sample size at registration | 50 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 25/05/2007 |
| Date of final enrolment | 31/08/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
3584 CA
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan | Not provided at time of registration |
Editorial Notes
27/10/2021: Proactive update review. No publications found. Search options exhausted.
