- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01130467
Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
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
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Sub-Investigator:
- MING-TAO YANG, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Normal control
|
|
pure ADHD
|
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:
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:
Parenting and teaching skill education
|
ADHD with comorbidity
|
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:
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:
Parenting and teaching skill education
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Chinese version of SNAP-IV Rating Scale
Time Frame: 8 weeks
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event-related potential
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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