Attention Deficit Disorders With HyperactivityNCT01130467
Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
An observational study of Attention Deficit Disorders With Hyperactivity and Attention Deficit Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial summary
The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Disorders With Hyperactivity, Attention Deficit Disorder, Hyperkinetic Syndrome
- What is being tested?
- methylphenidate, Atomoxetine and behavioral modification
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- How many people
- 150 participants
- Where
- 1 siteTaiwan
- Study dates
- Sep 2009to Dec 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- health children
- or clinical diagnosis of attention-deficit hyperactivity disorder
Who cannot join
- hearing impairment
- uncorrectable visual impairment
- epilepsy
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Children Hospital, National Taiwan University Hospital
Taipei, 100
MING-TAO YANG, MD, +886-2-8966-7000, mingtao.yang@msa.hinet.net
WANG-TSO LEE, MD, PhD, +886-2-23123456 ext. 71514, leeped@hotmail.com
About this study
The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.
Read the 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.
- Conditions
- Attention Deficit Disorders With Hyperactivity, Attention Deficit Disorder, Hyperkinetic Syndrome
- Being tested
- methylphenidate, Atomoxetine, behavioral modification
- Keywords
- Attention Deficit Disorders with Hyperactivity, Attention Deficit Disorder, Event related potential
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
methylphenidateDrug
Also called Ritalin, Concerta
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.
AtomoxetineDrug
Also called Straterra
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 modificationBehavioural
Parenting and teaching skill education
| Study group | Role | What they receive |
|---|---|---|
| Normal control | Not described | |
| pure ADHD | Not described Receives: Drug: methylphenidate; Drug: Atomoxetine; Behavioral: behavioral modification | |
| ADHD with comorbidity | Not described Receives: Drug: methylphenidate; Drug: Atomoxetine; Behavioral: behavioral modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese version of SNAP-IV Rating Scale
Measured: 8 weeks
Secondary outcomes (1)
Event-related potential
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorders With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Academia Sinica, Taiwan, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01130467
- Sponsor's protocol ID
- FEMH-IRB-098034-3
- Status last verified
- May 2010
- First submitted
- 24 May 2010
- Last updated
- 10 Aug 2010
- Results posted
- No
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.
PubMed 12559225
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Event-related Potentials in Management of Children With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01130467
- Acronym / sponsor ID
- FEMH-IRB-098034-3
- Conditions
- Attention Deficit Disorders With Hyperactivity, Attention Deficit Disorder, Hyperkinetic Syndrome
- Keywords
- Attention Deficit Disorders with Hyperactivity, Attention Deficit Disorder, Event related potential
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Collaborators
- Academia Sinica, Taiwan, National Taiwan University Hospital
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (estimated)
- First posted
- 26 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators try to objectively and scientifically explore various brain function impairments in ADHD children by electrophysiologic tests, with and without medication.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control | – | – |
| pure ADHD | – | Drug: methylphenidate, Drug: Atomoxetine, Behavioral: behavioral modification |
| ADHD with comorbidity | – | Drug: methylphenidate, Drug: Atomoxetine, Behavioral: behavioral modification |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- health children
- or clinical diagnosis of attention-deficit hyperactivity disorder
Key exclusion criteria (3 listed)
- hearing impairment
- uncorrectable visual impairment
- epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidateAlso: Ritalin, ConcertaIR-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. | Drug | ADHD with comorbidity, pure ADHD |
| AtomoxetineAlso: StraterraAtomexetine 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). | Drug | ADHD with comorbidity, pure ADHD |
| behavioral modificationParenting and teaching skill education | Behavioural | ADHD with comorbidity, pure ADHD |
Primary outcome
Chinese version of SNAP-IV Rating Scale
Time frame: 8 weeks
1 secondary outcome
Event-related potential
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2010.
- Background: PubMed 12559225Barry 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Children Hospital, National Taiwan University Hospital
Taipei, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorders With Hyperactivity and Attention Deficit Disorder, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese version of SNAP-IV Rating Scale (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01130467, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2010.