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

• Conditions: Attention Deficit Disorders With Hyperactivity; Attention Deficit Disorder; Hyperkinetic Syndrome
• Interventions: Drug: methylphenidate; Drug: Atomoxetine; Behavioral: behavioral modification

• Registration Number: NCT01130467
• Lead Sponsor: Far Eastern Memorial Hospital

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.

Study Timeline

• Study Start: 2009-09
• Status Verified: 2010-05
• Study First Submitted: 2010-05-24
• Study First Submitted QC: 2010-05-25
• Study First Posted: 2010-05-26
• Last Update Submitted: 2010-08-08
• Last Update Posted: 2010-08-10
• Primary Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

• hearing impairment
• uncorrectable visual impairment
• epilepsy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pure ADHD	behavioral modification	-
ADHD with comorbidity	behavioral modification	-
pure ADHD	Atomoxetine	-
pure ADHD	methylphenidate	-
ADHD with comorbidity	Atomoxetine	-
ADHD with comorbidity	methylphenidate	-

Primary Outcome Measures

Name	Time	Method
Chinese version of SNAP-IV Rating Scale	8 weeks

Secondary Outcome Measures

Name	Time	Method
Event-related potential	8 weeks

Trial Locations

Locations (1)

Children Hospital, National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan