NCT00842127

Brief Summary

The purpose of this study is to examine whether genetic polymorphisms in drug transporters were associated with the side effects of OROS-methylphenidate medication in attention deficit/hyperactivity disorder(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 Mar 2006

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 12, 2009

Completed
Last Updated

February 12, 2009

Status Verified

February 1, 2009

Enrollment Period

2.4 years

First QC Date

February 11, 2009

Last Update Submit

February 11, 2009

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

MethylphenidateADHDMultidrug resistance(MDR)polymorphismOROS methylphenidate

Outcome Measures

Primary Outcomes (1)

  • Barkley side effects rating scale

    weeks 1, 2,4,8

Secondary Outcomes (1)

  • ADHD rating scale-Korean version; Clinical Global Impressions (CGI) of Severity and Improvement (CGI-S and CGI-I)

    8 weeks

Interventions

OROS-methylphenidate (Concerta)DRUG

dose: 18mg, 27mg, 36mg, 45mg, 54mg/day, po duration: 8 weeks

Also known as: Concerta

Eligibility Criteria

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

You may qualify if:

  • ADHD
  • Must be able to swallow a capsule

You may not qualify if:

  • Pervasive developmental disorder
  • Mental retardation
  • Psychotic disorder
  • Bipolar disorder
  • Suicidality
  • Neurological disorder
  • Concurrent psychiatric treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bundang CHA hospital

Seongnam, Kyonggi-do, 463-712, South Korea

Location

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

  • Ki-Hwan Yook, MD,PhD

    Department of psychiatry CHA university college of medicine

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2009

First Posted

February 12, 2009

Study Start

March 1, 2006

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

February 12, 2009

Record last verified: 2009-02

Locations

KR(1)