Clinical trial NCT01912352: Gene-environment Interactions and Brain Functional Connectivity in Attention Deficit Hyperactivity Disorder
Official title: Gene-environment Interactions and Brain Functional Connectivity Associated With Norepinephrine System Genes in Attention Deficit Hyperactivity Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: ADHD
ADRA2A
Methylphenidate
Response
Lead sponsor: Seoul National University
Sponsor class: OTHER
Collaborators: name: Korea Research Foundation
First posted: 2013-07-31
Enrollment: 83
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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

Primary outcomes:
measure: Change From Baseline ADHD Rating Scale-IV Scores at 8 Weeks
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: Clinical Global Impression-Improvement Scale at 8 Weeks
timeFrame: baseline and 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Seoul National University and Seoul National University Hospital
name: Jae-Won Kim, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim JI, Kim JW, Shin I, Kim BN. Effects of Interaction Between DRD4 Methylation and Prenatal Maternal Stress on Methylphenidate-Induced Changes in Continuous Performance Test Performance in Youth with Attention-Deficit/Hyperactivity Disorder. J Child Adolesc Psychopharmacol. 2018 Oct;28(8):562-570. doi: 10.1089/cap.2018.0054. Epub 2018 Jun 15.
citation: Kim JW, Sharma V, Ryan ND. Predicting Methylphenidate Response in ADHD Using Machine Learning Approaches. Int J Neuropsychopharmacol. 2015 May 10;18(11):pyv052. doi: 10.1093/ijnp/pyv052.
citation: Hong SB, Zalesky A, Park S, Yang YH, Park MH, Kim B, Song IC, Sohn CH, Shin MS, Kim BN, Cho SC, Kim JW. COMT genotype affects brain white matter pathways in attention-deficit/hyperactivity disorder. Hum Brain Mapp. 2015 Jan;36(1):367-77. doi: 10.1002/hbm.22634. Epub 2014 Sep 9.