NCT00757029

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2005

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 22, 2008

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

October 5, 2011

Status Verified

December 1, 2010

Enrollment Period

2.8 years

First QC Date

September 19, 2008

Last Update Submit

October 4, 2011

Conditions

Attention Deficit Disorder With HyperactivityMethylphenidatePharmacogenetics

Keywords

ADHD,norepinephrine transporterpharmacogenetics

Outcome Measures

Primary Outcomes (1)

  • Korean ADHD Rating scale-parent version (KARS)

    baseline,1,2,4,8 weeks

Secondary Outcomes (1)

  • Barkely side effect rating scale

    1,2,4,8weeks

Study Arms (1)

open label

OTHER
Genetic: norepinephrine transporter polymorphism,

Interventions

norepinephrine transporter polymorphism,GENETIC

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
open label

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • ADHD
  • Physically healthy

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Sacred Heart Hospital

Anyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

MethylphenidateTimeNorepinephrine Plasma Membrane Transport ProteinsPolymorphism, Genetic

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhysical PhenomenaSymportersIon PumpsMembrane Transport ProteinsCarrier ProteinsProteinsAmino Acids, Peptides, and ProteinsCatecholamine Plasma Membrane Transport ProteinsPlasma Membrane Neurotransmitter Transport ProteinsNeurotransmitter Transport ProteinsSolute Carrier ProteinsMembrane ProteinsGenetic VariationGenetic Phenomena

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2008

First Posted

September 22, 2008

Study Start

October 1, 2005

Primary Completion

August 1, 2008

Study Completion

August 1, 2010

Last Updated

October 5, 2011

Record last verified: 2010-12

Locations

KR(1)