Attention Deficit Hyperactivity DisorderPhase 4NCT00862108
Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- Methylphenidate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2008to Mar 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Child, Adult
Who may be able to join
- diagnosis made by DSM-IV and K-SADS-PL
- IQ > 71
Who cannot join
- genetic disorder
- history of acquired brain injury
- seizure disorder
- other neurologic disorder
- mental disorder, pervasive developmental disorder
- obsessive-Compulsive disorder
- communication disorder
- learning disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-769
Soo-Churl Cho, MD, PhD
About this study
Official title: Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD
The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Methylphenidate
- Keywords
- Attention Deficit Hyperactivity Disorder, Polymorphism, Single Nucleotide, SLC6A2 protein, human, ADRA2A protein, human
- 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 Concerta OROS, Metadate CD, Penid
mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate | Experimental | Not described Receives: Drug: Methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Global Impression Scale-Improvement
Measured: 8 weeks
Secondary outcomes (1)
ADHD rating scale
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 posted16 Mar 2009 (estimated)
- Study startSep 2008
- Primary completionMar 2010 (estimated)
- Study completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Investigators
- Soo-Churl Cho, MD, PhD, Principal investigator, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00862108
- Sponsor's protocol ID
- A080054
- Status last verified
- Sep 2009
- First submitted
- 5 Mar 2009
- Last updated
- 22 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD
- ClinicalTrials.gov ID
- NCT00862108
- Acronym / sponsor ID
- A080054
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, Polymorphism, Single Nucleotide, SLC6A2 protein, human, ADRA2A protein, human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Korea Health Industry Development Institute
- Study start
- Sep 2008
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Mar 2010 (estimated)
- First posted
- 16 Mar 2009 (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 purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate | Experimental | Drug: Methylphenidate |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- diagnosis made by DSM-IV and K-SADS-PL
- IQ > 71
Key exclusion criteria (8 listed)
- genetic disorder
- history of acquired brain injury
- seizure disorder
- other neurologic disorder
- mental disorder, pervasive developmental disorder
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: Concerta OROS, Metadate CD, Penidmg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks | Drug | Methylphenidate |
Primary outcome
Clinical Global Impression Scale-Improvement
Time frame: 8 weeks
1 secondary outcome
ADHD rating scale
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 22 Sep 2009.
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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.
Soo-Churl Cho, MD, PhD principal investigator
Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylphenidate in people with Attention Deficit Hyperactivity Disorder, run by Seoul National University Hospital at 1 site in South Korea.
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 8 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 22 Sep 2009. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Soo-Churl Cho, MD, PhD (82-2-2072-3648, jewook.kang@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Global Impression Scale-Improvement (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Sep 2009.