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

Attention Deficit Disorder Clinical Trial

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01130467
• Other study ID #: FEMH-IRB-098034-3
• Status: Unknown status
• Phase: Phase 4
• First received: May 24, 2010
• Last updated: August 8, 2010
• Start date: September 2009

Study information

• Verified date: May 2010
• Source: Far Eastern Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 150
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria:

• health children

• or clinical diagnosis of attention-deficit hyperactivity disorder

Exclusion Criteria:

• hearing impairment

• uncorrectable visual impairment

• epilepsy

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Disorders With Hyperactivity
• Disease
• Hyperkinesis
• Hyperkinetic Syndrome

Intervention

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.
• 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).

Behavioral:
• behavioral modification
Parenting and teaching skill education

Locations

Country	Name	City	State
Taiwan	Children Hospital, National Taiwan University Hospital	Taipei

Sponsors (3)

Lead Sponsor	Collaborator
Far Eastern Memorial Hospital	Academia Sinica, Taiwan, National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chinese version of SNAP-IV Rating Scale		8 weeks
Secondary	Event-related potential		8 weeks