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 number	Nil Known
Secondary identifying numbers	P06-160C, NL969 (NTR996)

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr A.E. Wester
Scientific

Utrecht Institute for Pharmaceutical Sciences
Utrecht University
Utrecht
3584 CA
Netherlands

Phone	+31(0)30 253 7768
Email	A.E.Wester@uu.nl

Study information

Study design	Clinical trial
Primary study design	Interventional
Secondary study design	Single-centre
Study setting(s)	Hospital
Study type	Not Specified
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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methylphenidate
Primary outcome measure	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 study start date	25/05/2007
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 number of participants	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

Utrecht Institute for Pharmaceutical Sciences

Utrecht
3584 CA
Netherlands

Sponsor information

Utrecht Institute for Pharmaceutical Sciences (The Netherlands)
Research organisation

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

Website	http://www.pharm.uu.nl/ffwuk.htm?/uips/
"ROR"	https://ror.org/04pp8hn57

Funders

Funder type

Research organisation

Utrecht Institute for Pharmaceutical Sciences (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	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.