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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Functional Brain Markers and Predictors of Treatment Response Associated With Norepinephrine System Genes in ADHD

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00862108
• Other study ID #: A080054
• Status: Recruiting
• Phase: Phase 4
• First received: March 5, 2009
• Last updated: September 20, 2009
• Start date: September 2008
• Est. completion date: March 2010

Study information

• Verified date: September 2009
• Source: Seoul National University Hospital
• Contact: Soo-Churl Cho, MD, PhD
• Phone: 82-2-2072-3648
• Email: jewook.kang[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• Methylphenidate
mg/kg dose: 0.7~1.2mg/kg PO daily morning intake 8 weeks

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Korea Health Industry Development Institute

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression Scale-Improvement		8 weeks	No
Secondary	ADHD rating scale		8 weeks	No