Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder

NCT ID: NCT01130467

Last Updated: 2010-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Attention Deficit Disorders With Hyperactivity Attention Deficit Disorder Hyperkinetic Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Normal control

No interventions assigned to this group

pure ADHD

methylphenidate

Intervention Type DRUG

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.

Atomoxetine

Intervention Type DRUG

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).

behavioral modification

Intervention Type BEHAVIORAL

Parenting and teaching skill education

ADHD with comorbidity

methylphenidate

Intervention Type DRUG

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.

Atomoxetine

Intervention Type DRUG

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).

behavioral modification

Intervention Type BEHAVIORAL

Parenting and teaching skill education

Interventions

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methylphenidate

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.

Intervention Type DRUG

Atomoxetine

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).

Intervention Type DRUG

behavioral modification

Parenting and teaching skill education

Intervention Type BEHAVIORAL

Other Intervention Names

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Ritalin, Concerta Straterra

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* hearing impairment
* uncorrectable visual impairment
* epilepsy
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Academia Sinica, Taiwan

OTHER

Sponsor Role collaborator

National Taiwan University Hospital

OTHER

Sponsor Role collaborator

Far Eastern Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

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Department of Pediatrics, Far Eastern Memorial Hospital

Locations

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Children Hospital, National Taiwan University Hospital

Taipei, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Facility Contacts

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MING-TAO YANG, MD

Role: primary

+886-2-8966-7000

WANG-TSO LEE, MD, PhD

Role: backup

+886-2-23123456 ext. 71514

References

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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.

Reference Type BACKGROUND
PMID: 12559225 (View on PubMed)

Other Identifiers

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FEMH-IRB-098034-3

Identifier Type: -

Identifier Source: org_study_id

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