Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD) - Full Text View

Sponsor:	Hallym University Medical Center
Information provided by (Responsible Party):	Hallym University Medical Center
ClinicalTrials.gov Identifier:	NCT00757029

Purpose

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.

Condition	Intervention	Phase
Attention Deficit Disorder With Hyperactivity Methylphenidate Pharmacogenetics	Genetic: norepinephrine transporter polymorphism,	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate

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: Norepinephrine Methylphenidate Norepinephrine bitartrate Methylphenidate hydrochloride

U.S. FDA Resources

Further study details as provided by Hallym University Medical Center:

Primary Outcome Measures:

Korean ADHD Rating scale-parent version (KARS) [ Time Frame: baseline,1,2,4,8 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Barkely side effect rating scale [ Time Frame: 1,2,4,8weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	150
Study Start Date:	October 2005
Study Completion Date:	August 2010
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
open label	Genetic: norepinephrine transporter polymorphism, OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism Other Names: OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism

Eligibility

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

Criteria

Inclusion Criteria:

ADHD
Physically healthy

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00757029

Locations

Korea, Republic of
Hallym University Sacred Heart Hospital
Anyang, Gyeonggi-do, Korea, Republic of

Sponsors and Collaborators

Hallym University Medical Center

More Information

No publications provided

Responsible Party:	Hallym University Medical Center
ClinicalTrials.gov Identifier:	NCT00757029 History of Changes
Other Study ID Numbers:	NETADHD
Study First Received:	September 19, 2008
Last Updated:	October 4, 2011
Health Authority:	South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Hallym University Medical Center:

ADHD,
norepinephrine transporter
pharmacogenetics

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
Norepinephrine
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
Sympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Vasoconstrictor Agents
Cardiovascular Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents

ClinicalTrials.gov processed this record on February 09, 2012