MedDataX Logo

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

NCT ID: NCT01912352

Last Updated: 2014-12-04

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2013-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Methylphenidate

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Methylphenidate

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Korea Research Foundation

OTHER

Sponsor Role collaborator

Seoul National University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jae-Won Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jae-Won Kim, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Seoul National University and Seoul National University Hospital

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 29905488 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25964505 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25201318 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2010-0002283

Identifier Type: -

Identifier Source: org_study_id