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

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

Study Overview

• Status: Unknown
• Conditions: Attention Deficit Disorder; Attention Deficit Disorders With Hyperactivity; Hyperkinetic Syndrome
• Intervention / Treatment: Drug: methylphenidate; Drug: Atomoxetine; Behavioral: behavioral modification

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 Type: Observational
• Enrollment (Anticipated): 150

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • Children Hospital, National Taiwan University Hospital
    • Contact: MING-TAO YANG, MD; Phone Number: +886-2-8966-7000; Email: mingtao.yang@msa.hinet.net
    • Contact: WANG-TSO LEE, MD, PhD; Phone Number: 71514 +886-2-23123456; Email: leeped@hotmail.com
    • Sub-Investigator: MING-TAO YANG, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• hearing impairment
• uncorrectable visual impairment
• epilepsy

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Normal control
pure ADHD	Drug: 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.; Other Names: Ritalin, Concerta; 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).; Other Names: Straterra; Behavioral: behavioral modification; Parenting and teaching skill education
ADHD with comorbidity	Drug: 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.; Other Names: Ritalin, Concerta; 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).; Other Names: Straterra; Behavioral: behavioral modification; Parenting and teaching skill education

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Chinese version of SNAP-IV Rating Scale	8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Event-related potential	8 weeks

Collaborators and Investigators

• Sponsor: Far Eastern Memorial Hospital
• Collaborators: National Taiwan University Hospital; Academia Sinica, Taiwan

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (ANTICIPATED): December 1, 2011

Study Registration Dates

• First Submitted: May 24, 2010
• First Submitted That Met QC Criteria: May 25, 2010
• First Posted (ESTIMATE): May 26, 2010

Study Record Updates

• Last Update Posted (ESTIMATE): August 10, 2010
• Last Update Submitted That Met QC Criteria: August 8, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Attention Deficit Disorders with Hyperactivity; Attention Deficit Disorder; Event related potential
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Disease; Attention Deficit Disorder with Hyperactivity; Hyperkinesis; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Dopamine Agents; Dopamine Uptake Inhibitors; Central Nervous System Stimulants; Adrenergic Uptake Inhibitors; Methylphenidate; Atomoxetine Hydrochloride
• Other Study ID Numbers: FEMH-IRB-098034-3