Pharmacogenetic Study of Methylphenidate in Attention Deficit/Hyperactivity Disorder(ADHD)

Attention Deficit Disorder With Hyperactivity Clinical Trial

— NETADHD  

Official title:

Association Between Norepinephrine Transporter Polymorphism and Response of Methylphenidate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00757029
• Other study ID #: NETADHD
• Status: Completed
• Phase: Phase 4
• First received: September 19, 2008
• Last updated: October 4, 2011
• Start date: October 2005
• Est. completion date: August 2010

Study information

• Verified date: December 2010
• Source: Hallym University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: August 2010
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis
• Methylphenidate
• Pharmacogenetics

Intervention

Genetic:
• norepinephrine transporter polymorphism,
OROS methylphenidate (Concerta) monopharmacotherapy dose : 18-54mg duration : 8 weeks genotyping : norepinephrine transporter (SLC6A2) polymorphism

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Korean ADHD Rating scale-parent version (KARS)		baseline,1,2,4,8 weeks	Yes
Secondary	Barkely side effect rating scale		1,2,4,8weeks	Yes