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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Far Eastern Memorial Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Academia Sinica, Taiwan
National Taiwan University Hospital
Information provided by:
Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier:
NCT01130467
First received: May 24, 2010
Last updated: August 8, 2010
Last verified: May 2010
  Purpose

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


Condition Intervention Phase
Attention Deficit Disorders With Hyperactivity
Attention Deficit Disorder
Hyperkinetic Syndrome
Drug: methylphenidate
Drug: Atomoxetine
Behavioral: behavioral modification
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Far Eastern Memorial Hospital:

Primary Outcome Measures:
  • Chinese version of SNAP-IV Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Event-related potential [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: 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 Name: 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 Name: Straterra
Behavioral: behavioral modification
Parenting and teaching skill education

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.

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • hearing impairment
  • uncorrectable visual impairment
  • epilepsy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130467

Locations
Taiwan
Children Hospital, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: MING-TAO YANG, MD    +886-2-8966-7000    mingtao.yang@msa.hinet.net   
Contact: WANG-TSO LEE, MD, PhD    +886-2-23123456 ext 71514    leeped@hotmail.com   
Principal Investigator: WANG-TSO LEE, MD, PhD         
Sub-Investigator: MING-TAO YANG, MD         
Sponsors and Collaborators
Far Eastern Memorial Hospital
Academia Sinica, Taiwan
National Taiwan University Hospital
  More Information

Publications:
Responsible Party: MING-TAO YANG, Department of Pediatrics, Far Eastern Memorial Hospital
ClinicalTrials.gov Identifier: NCT01130467     History of Changes
Other Study ID Numbers: FEMH-IRB-098034-3
Study First Received: May 24, 2010
Last Updated: August 8, 2010
Health Authority: Taiwan: Department of Health

Keywords provided by Far Eastern Memorial Hospital:
Attention Deficit Disorders with Hyperactivity
Attention Deficit Disorder
Event related potential

Additional relevant MeSH terms:
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Atomoxetine
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses
Adrenergic Uptake Inhibitors
Adrenergic Agents

ClinicalTrials.gov processed this record on April 23, 2014