Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
Recruitment status was Recruiting
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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 |
- Chinese version of SNAP-IV Rating Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- 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 |
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.
Inclusion Criteria:
- health children
- or clinical diagnosis of attention-deficit hyperactivity disorder
Exclusion Criteria:
- hearing impairment
- uncorrectable visual impairment
- epilepsy
Contacts and 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 | |
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 May 23, 2013