Methylphenidate Treatment Response Study of Genetic Polym... | NCT00862108

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

NCT00862108

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Sep 22, 2009Estimated

Enrollment

50Estimated

Phase

Phase 4

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

Methylphenidate

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2008

Primary Completion Date

Mar 2010Estimated

Completion Date

Mar 2010Estimated

First Submitted Date

Mar 5, 2009

First Submission Date that Met QC Criteria

Mar 13, 2009

First Posted Date

Mar 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2009

Last Update Posted Date

Sep 22, 2009Estimated

Name	Class
Korea Health Industry Development Institute	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Methylphenidate	Experimental		Drug: Methylphenidate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Methylphenidate	Drug	mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks	Methylphenidate

Measure	Description	Time Frame
Clinical Global Impression Scale-Improvement		8 weeks

Measure	Description	Time Frame
ADHD rating scale		8 weeks

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Soo-Churl Cho, MD, PhD	Contact	82-2-2072-3648		jewook.kang@gmail.com

Overall Officials

Name	Affiliation	Role
Soo-Churl Cho, MD, PhD	Seoul National University College of Medicine	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul		110-769	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D001289	Attention Deficit Disorder with Hyperactivity

Ancestor Terms

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008774	Methylphenidate

Ancestor Terms

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals

Browse Leaves

Not provided

Browse Branches

Not provided