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CompletedNCT00757029NETADHDUpdated Oct 5, 2011

Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)

A Phase 4 interventional study of norepinephrine transporter polymorphism, in Attention Deficit Disorder With Hyperactivity, Methylphenidate and Pharmacogenetics, sponsored by Hallym University Medical Center. Completed at 1 site in Korea, Republic of. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2011-10-05.

Sponsored by Hallym University Medical Center · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
150
Allocation
Non-randomized
Ages
6 Years to 18 Years
Sex
All
01

Study 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). The investigators hypothesis is that norepinephrine transporter polymorphism is associated with responses and adverse effects of OROS-methylphenidate in treatment of ADHD.

02

Conditions studied

  • Attention Deficit Disorder With Hyperactivity
  • Methylphenidate
  • Pharmacogenetics

Keywords

  • ADHD,
  • norepinephrine transporter
  • pharmacogenetics
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In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's planned enrollment of 150 is above the median of 80 across 583 interventional studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Hallym University Medical Center is the lead sponsor of 52 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ADHD
  • Physically healthy

Exclusion criteria

Exclusion Criteria:

  • Neurological illness
  • Concurrent additional psychiatric treatment
  • \< IQ 70
  • Psychotic disorder
  • Major mood disorder needed other psychiatric medication
  • Significant suicidal ideation
  • Pervasive developmental disorder
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
150 participants (estimated)

Study arms

  • Other
    open label

    Genetic: norepinephrine transporter polymorphism,

Interventions

  • Geneticnorepinephrine transporter polymorphism,

    OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism

    Also known as: OROS methylphenidate (Concerta) monopharmacotherapy, dose : 18-54mg, duration : 8 weeks, genotyping : norepinephrine transporter (SLC6A2) polymorphism

06

What researchers measure

Primary outcomes

  1. Korean ADHD Rating scale-parent version (KARS)

    Time frame: baseline,1,2,4,8 weeks

Secondary outcomes

  1. Barkely side effect rating scale

    Time frame: 1,2,4,8weeks

07

Study locations

1 site
  • Hallym University Sacred Heart Hospital
    Anyang, Gyeonggi-do, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00757029
Lead sponsor
Hallym University Medical Center
Responsible party
Sponsor
First posted
Sep 22, 2008
Start date
Oct 2005
Primary completion
Aug 2008
Completion
Aug 2010
Last update
Oct 5, 2011

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.

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