Methylphenidate Treatment Response Study of Genetic Polymorphism in Attention Deficit Hyperactivity Disorder(ADHD)

The recruitment status of this study is unknown because the information has not been verified recently.

Verified September 2009 by Seoul National University Hospital. Recruitment status was Recruiting

First Received on March 5, 2009. Last Updated on September 20, 2009 History of Changes

Sponsor:	Seoul National University Hospital
Collaborator:	Korea Health Industry Development Institute
Information provided by:	Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00862108

Purpose

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

Condition	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: Methylphenidate	Phase IV

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD

Resource links provided by NLM:

Genetics Home Reference related topics: Help Me Understand Genetics

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:

Clinical Global Impression Scale-Improvement [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

ADHD rating scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	September 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Methylphenidate	Drug: Methylphenidate mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks Other Names: Concerta OROS Metadate CD Penid

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00862108

Contacts

Contact: Soo-Churl Cho, MD, PhD

82-2-2072-3648

jewook.kang@gmail.com

Locations

Korea, Republic of
Seoul National University Hospital	Recruiting
Seoul, Korea, Republic of, 110-769
Principal Investigator: Soo-Churl Cho, MD, PhD

Sponsors and Collaborators

Seoul National University Hospital

Korea Health Industry Development Institute

Investigators

Principal Investigator:

Soo-Churl Cho, MD, PhD

Seoul National University College of Medicine

More Information

No publications provided

Responsible Party:	Je-Wook, Kang, Seoul National University Hospital
ClinicalTrials.gov Identifier:	NCT00862108 History of Changes
Other Study ID Numbers:	A080054
Study First Received:	March 5, 2009
Last Updated:	September 20, 2009
Health Authority:	South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:

Attention Deficit Hyperactivity Disorder
Polymorphism, Single Nucleotide
SLC6A2 protein, human
ADRA2A protein, human

Additional relevant MeSH terms:

Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate

Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Central Nervous System Stimulants
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012