Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder

Not Applicable

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: Methylphenidate

• Registration Number: NCT01912352
• Lead Sponsor: Seoul National University

Brief Summary

The aims of the current study are to examine gene-environment interactions associated with norepinephrine (NE) system genes (ADRA2A, SLC6A2) in ADHD, and to evaluate whether genetic changes in norepinephrine pathway are associated with differences in functional connectivity of white matter fiber tracts, as measured by diffusion tensor imaging (DTI). Furthermore, this study aims to examine neurobiological markers, such as intermediate neuroimaging phenotypes or neuropsychological endophenotypes associated with the pathophysiology of ADHD. Through evaluating drug responses and side effects with the associated measures of clinical, neuropsychological and neuroimaging characteristics, investigators would like to investigate predictors of treatment response associated with NE system genes in ADHD.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Study First Submitted: 2013-07-16
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Status Verified: 2014-11
• Results First Submitted: 2014-11-20
• Results First Submitted QC: 2014-11-26
• Last Update Submitted: 2014-11-26
• Results First Posted: 2014-12-04
• Last Update Posted: 2014-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

Inclusion Criteria

• Clinical diagnosis of Attention-deficit Hyperactivity Disorder
• 6-18 years old

Exclusion Criteria

• History of neurological diseases, including convulsive disorders or brain damage
• IQ below 70
• Pervasive developmental disorder (autism)
• Language difficulties or learning disorders (reading disorders, mathematics disorders and disorders of written expression).
• Tourette's syndrome
• Bipolar disorder
• Psychosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Methylphenidate	Methylphenidate	Participants were treated with methylphenidate (ranging from to 63mg) for 8 weeks. Doses of methylphenidate were titrated depending on symptoms and adverse eff ects at the 2nd and 4th weeks of treatment.

Primary Outcome Measures

Name	Time	Method
Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks	baseline and 8 weeks	Attendtion-deficit hyperactivity disorder (ADHD) Rating Scale-IV is the sum of 18 questions, ranging from 0 (no symptoms) to 54 (worst possible symptoms).; Change from baseline ADHD Rating Scale-IV scores at 8 weeks was calculated as baseline minus 8 weeks.

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression-Improvement Scale at 8 Weeks	baseline and 8 weeks	Clinical Global Impression-Improvement (CGI-I) scale is a one-item measure evaluating the change from the initiation of treatment on a seven-point scale: "Compared to the patient's condition at baseline \[prior to medication initiation\], this patient's condition is: 1=very much improved since the initiation of treatment; 2=much improved; 3=minimally improved; 4=no change from baseline (the initiation of treatment); 5=minimally worse; 6= much worse; 7=very much worse since the initiation of treatment.; Clinical Global Impression-Improvement was measured at 8 weeks.