NCT01912352

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2010

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

December 4, 2014

Completed
Last Updated

December 4, 2014

Status Verified

November 1, 2014

Enrollment Period

2.9 years

First QC Date

July 16, 2013

Results QC Date

November 20, 2014

Last Update Submit

November 26, 2014

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDADRA2AMethylphenidateResponse

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Clinical Global Impression-Improvement Scale at 8 Weeks

    baseline and 8 weeks

Study Arms (1)

Methylphenidate

EXPERIMENTAL

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

Interventions

MethylphenidateDRUG
Methylphenidate

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of Attention-deficit Hyperactivity Disorder
  • years old

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 29905488DERIVED

  • 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.

    PMID: 25964505DERIVED

  • 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.

    PMID: 25201318DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Dr. Jae-Won Kim
Organization
Seoul National University
adore412@paran.com
822-2072-3648

Study Officials

  • Jae-Won Kim, MD., PhD.

    Seoul National University and Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 16, 2013

First Posted

July 31, 2013

Study Start

May 1, 2010

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

December 4, 2014

Results First Posted

December 4, 2014

Record last verified: 2014-11