Attention Deficit Disorder With HyperactivityPhase 4NETADHDNCT00757029
Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)
A Phase 4 study testing norepinephrine transporter polymorphism, in people with Attention Deficit Disorder With Hyperactivity and Methylphenidate, run by Hallym University Medical Center at 1 site in South Korea.
Trial summary
The noradrenergic system plays a known role in attentional systems and suspected causal role in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as a inhibitor of norepinephrine transporter(SLC6A2). Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Methylphenidate, Pharmacogenetics
- What is being tested?
- norepinephrine transporter polymorphism,
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2005to Aug 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
- ADHD
- Physically healthy
Who cannot join
- Neurological illness
- Concurrent additional psychiatric treatment
- < IQ 70
- Psychotic disorder
- Major mood disorder needed other psychiatric medication
- Significant suicidal ideation
- Pervasive developmental disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Hallym University Sacred Heart Hospital
Anyang-si, Gyeonggi-do
About this study
Official title: Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate
The noradrenergic system plays a known role in attentional systems and suspected causal role in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that norepinephrine transporter polymorphism is associated with responses and adverse effects of OROS-methylphenidate in treatment of ADHD.
- Being tested
- norepinephrine transporter polymorphism,
- Keywords
- ADHD,, norepinephrine transporter, pharmacogenetics
- 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.
norepinephrine transporter polymorphism,Genetic
Also called OROS methylphenidate (Concerta) monopharmacotherapy, dose : 18-54mg, duration : 8 weeks, genotyping : norepinephrine transporter (SLC6A2) polymorphism
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism
| Study group | Role | What they receive |
|---|---|---|
| open label | Other | Not described Receives: Genetic: norepinephrine transporter polymorphism, |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean ADHD Rating scale-parent version (KARS)
Measured: baseline,1,2,4,8 weeks
Secondary outcomes (1)
Barkely side effect rating scale
Measured: 1,2,4,8weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2008 (estimated)
- Study startOct 2005
- Primary completionAug 2008
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Disorder 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hallym University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00757029
- Sponsor's protocol ID
- NETADHD
- Acronym
- NETADHD
- Status last verified
- Dec 2010
- First submitted
- 19 Sep 2008
- Last updated
- 5 Oct 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate
- ClinicalTrials.gov ID
- NCT00757029
- Acronym / sponsor ID
- NETADHD / NETADHD
- Keywords
- ADHD,, norepinephrine transporter, pharmacogenetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hallym University Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- Primary completion
- Aug 2008 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 22 Sep 2008 (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 noradrenergic system plays a known role in attentional systems and suspected causal role in attention deficit/hyperactivity disorder(ADHD).Methylphenidate also has been suspected as a inhibitor of norepinephrine transporter(SLC6A2). The investigators hypothesis is that norepinephrine transporter polymorphism is associated with responses and adverse effects of OROS-methylphenidate in treatment of ADHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| open label | Other | Genetic: norepinephrine transporter polymorphism, |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- ADHD
- Physically healthy
Key exclusion criteria (7 listed)
- Neurological illness
- Concurrent additional psychiatric treatment
- < IQ 70
- Psychotic disorder
- Major mood disorder needed other psychiatric medication
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 |
|---|---|---|
| norepinephrine transporter polymorphism,Also: OROS methylphenidate (Concerta) monopharmacotherapy, dose : 18-54mg, duration : 8 weeks, genotyping : norepinephrine transporter (SLC6A2) polymorphismOROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism | Genetic | open label |
Primary outcome
Korean ADHD Rating scale-parent version (KARS)
Time frame: baseline,1,2,4,8 weeks
1 secondary outcome
Barkely side effect rating scale
Time frame: 1,2,4,8weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 norepinephrine transporter polymorphism, in people with Attention Deficit Disorder With Hyperactivity and Methylphenidate, run by Hallym University Medical Center 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 7 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: finished, as of the sponsor's last update on 5 Oct 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean ADHD Rating scale-parent version (KARS) (time frame: baseline,1,2,4,8 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 5 Oct 2011.