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NCT Number: NCT01912352

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

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.

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylphenidate

Drug

Primary outcomes

  1. Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks

    Time frame: 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 outcomes

  1. Clinical Global Impression-Improvement Scale at 8 Weeks

    Time frame: 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.

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Sponsors and collaborators

Lead sponsor

Seoul National University

Other

Collaborators

  • Korea Research Foundation

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Jul 31, 2013
Registry last updated
Dec 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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