NCT00862108

Brief Summary

The purpose of this study is to determine whether norepinephrine gene polymorphism affect to treatment response in ADHD

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2008

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2009

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 16, 2009

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

1.5 years

First QC Date

March 5, 2009

Last Update Submit

September 20, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Attention Deficit Hyperactivity DisorderPolymorphism, Single NucleotideSLC6A2 protein, humanADRA2A protein, human

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Impression Scale-Improvement

    8 weeks

Secondary Outcomes (1)

  • ADHD rating scale

    8 weeks

Study Arms (1)

Methylphenidate

EXPERIMENTAL
Drug: Methylphenidate

Interventions

MethylphenidateDRUG

mg/kg dose: 0.7\~1.2mg/kg PO daily morning intake 8 weeks

Also known as: Concerta OROS, Metadate CD, Penid
Methylphenidate

Eligibility Criteria

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

You may qualify if:

  • diagnosis made by DSM-IV and K-SADS-PL
  • IQ \> 71

You may not qualify if:

  • genetic disorder
  • history of acquired brain injury
  • seizure disorder
  • other neurologic disorder
  • mental disorder, pervasive developmental disorder
  • obsessive-Compulsive disorder
  • communication disorder
  • learning disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 110-769, South Korea

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Soo-Churl Cho, MD, PhD

    Seoul National University College of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Soo-Churl Cho, MD, PhD

CONTACT

82-2-2072-3648jewook.kang@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 5, 2009

First Posted

March 16, 2009

Study Start

September 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

KR(1)