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

Attention Deficit Hyperactivity Disorder Clinical Trial

Official title:

Gene-environment Interactions and Brain Functional Connectivity Associated With Norepinephrine System Genes in Attention Deficit Hyperactivity Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01912352
• Other study ID #: 2010-0002283
• Status: Completed
• Phase: N/A
• First received: July 16, 2013
• Last updated: November 26, 2014
• Start date: May 2010
• Est. completion date: April 2013

Study information

• Verified date: November 2014
• Source: Seoul National University
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

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

Intervention

Drug:
• Methylphenidate

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University	Korea Research Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline ADHD Rating Scale-IV Scores at 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.	baseline and 8 weeks	No
Secondary	Clinical Global Impression-Improvement Scale at 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.	baseline and 8 weeks	No