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

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ClinicalTrials.gov Identifier: NCT01912352
Recruitment Status : Completed
First Posted : July 31, 2013
Results First Posted : December 4, 2014
Last Update Posted : December 4, 2014
Sponsor:
Collaborator:
Korea Research Foundation
Information provided by (Responsible Party):
Jae-Won Kim, 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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: Methylphenidate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Gene-environment Interactions and Brain Functional Connectivity Associated With Norepinephrine System Genes in Attention Deficit Hyperactivity Disorder
Study Start Date : May 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013


Arm Intervention/treatment
Experimental: 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.
Drug: Methylphenidate



Primary Outcome Measures :
  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 Outcome Measures :
  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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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01912352


Sponsors and Collaborators
Seoul National University
Korea Research Foundation
Investigators
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Principal Investigator: Jae-Won Kim, MD., PhD. Seoul National University and Seoul National University Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jae-Won Kim, Professor, Seoul National University
ClinicalTrials.gov Identifier: NCT01912352    
Other Study ID Numbers: 2010-0002283
First Posted: July 31, 2013    Key Record Dates
Results First Posted: December 4, 2014
Last Update Posted: December 4, 2014
Last Verified: November 2014
Keywords provided by Jae-Won Kim, Seoul National University:
ADHD
ADRA2A
Methylphenidate
Response
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents