Clinical trial NCT01130467: Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Attention Deficit Disorders With Hyperactivity
Attention Deficit Disorder
Hyperkinetic Syndrome
Keywords: Attention Deficit Disorders with Hyperactivity
Attention Deficit Disorder
Event related potential
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Academia Sinica, Taiwan
name: National Taiwan University Hospital
First posted: 2010-05-26
Enrollment: 150
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: One hundred and fifty children, aged 6-18 years old, are enrolled. ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively. Urine pregnancy test is performed to exclude pregnant participants. Each participant is evaluated by both pediatric neurologists and child psychiatrists after enrollment to delineate possible underlying comorbidities. Three groups of participants were assigned: normal control group, pure ADHD group and ADHD with comorbidity group.

Brief summary: The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.

Detailed description: The aims of this study are to explore the various cognitive impairments of ADHD children, to differentiate various subtypes of ADHD children, and to investigate the efficacy of anti-ADHD drugs on various cognitive performance of ADHD children by event-related potentials(ERP).

Children, aged six to 18 years old, are enrolled and assigned to three groups (normal control, pure ADHD, and ADHD with comorbidities). ADHD children fulfill the DSM-IV-TR criteria for the diagnosis of ADHD. ADHD children are evaluated by Chinese version of SNAP-IV Rating Scale for rating ADHD-related symptoms before and after medication. EEG and audiometric testing are required for every participant to exclude dialeptic seizures and hearing impairment respectively.

Methylphenidate (either immediate-release or extended-release formulations) or atomoxetine Hydrochloride is given to ADHD participants.Continuous performance task (CPT) and ERP tasks are applied.

Eligibility criteria: Inclusion Criteria:

* health children
* or clinical diagnosis of attention-deficit hyperactivity disorder

Exclusion Criteria:

* hearing impairment
* uncorrectable visual impairment
* epilepsy

Primary outcomes:
measure: Chinese version of SNAP-IV Rating Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Event-related potential
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Children Hospital, National Taiwan University Hospital
Study officials:
References:
citation: Barry RJ, Johnstone SJ, Clarke AR. A review of electrophysiology in attention-deficit/hyperactivity disorder: II. Event-related potentials. Clin Neurophysiol. 2003 Feb;114(2):184-98. doi: 10.1016/s1388-2457(02)00363-2.