Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
1 other identifier
observational
150
1 country
1
Brief Summary
The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 24, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedAugust 10, 2010
May 1, 2010
2.2 years
May 24, 2010
August 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Chinese version of SNAP-IV Rating Scale
8 weeks
Secondary Outcomes (1)
Event-related potential
8 weeks
Study Arms (3)
Normal control
pure ADHD
ADHD with comorbidity
Interventions
IR-MPH were started on a dose of 5 mg tid po, and this was increased to 10 mg tid and then to 15 mg tid as necessary. OROS-MPH was started on a dose of 18 mg qd, and this was increased to 36 mg qd and then to 54 mg qd as necessary.
Atomexetine was started (weight of 70 kg or less) 0.5 mg/kg/day orally and increased after a minimum of 3 days to a target dose of 1.2 mg/kg/day. The maximum dosage is 1.4 mg/kg/day or 100 mg/day (whichever is less).
Parenting and teaching skill education
Eligibility Criteria
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.
You may qualify if:
- health children
- or clinical diagnosis of attention-deficit hyperactivity disorder
You may not qualify if:
- hearing impairment
- uncorrectable visual impairment
- epilepsy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Far Eastern Memorial Hospitallead
- Academia Sinica, Taiwancollaborator
- National Taiwan University Hospitalcollaborator
Study Sites (1)
Children Hospital, National Taiwan University Hospital
Taipei, 100, Taiwan
Related Publications (1)
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.
PMID: 12559225BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 24, 2010
First Posted
May 26, 2010
Study Start
September 1, 2009
Primary Completion
December 1, 2011
Last Updated
August 10, 2010
Record last verified: 2010-05