NCT01052753

Brief Summary

The ultimate goal of this study is to find specific polymorphism of candidate genes (particularly of dopaminergic and noradrenergic systems) associated with intermediate phenotypes (e.g., executive functions, IQ, and other neuropsychological function) and/or phenomenological phenotypes (subtypes, comorbidity, dimensional approach) of ADHD. We propose to replicate the analysis of the candidate genes identified by previous genetic studies and recent findings from GWAS on ADHD using the candidate gene association study design (family-based case control study using parental controls and population-based case-control study). These results may lead our research team: (1) to resolve controversies over inconsistent findings in previous genetic studies and contribute to the literature on the validity of ADHD and its subtypes using clinical and genetic data; (2) to identify potential endophenotypes for ADHD genetic studies; and (3) to identify specific polymorphism of candidate genes and gene expressions of dopaminergic and noradrenergic systems associated with executive functions measured by the CANTAB.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2013

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

3 years

First QC Date

January 18, 2010

Last Update Submit

September 1, 2021

Conditions

Keywords

Attention-deficit/hyperactivity disorderexecutive functionendophenotypedopaminergic systemnoradrenergic systemcandidate geneFamily-based association study

Study Arms (2)

ADHD group

Control group

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The proband sample will consist of at least 150 drug-naïve children and adolescents with ADHD, aged 7-18 (who are able to perform the CANTAB and time tasks) from Department of Psychiatry, National Taiwan University Hospital (NTUH). Their biological parents (n = 300) and siblings (estimated number = 150) born to the same biological parents will be recruited as the parent controls and sibling controls, respectively, for the family-based case control study. We will recruit 150 school controls without lifetime diagnosis of ADHD in the same school districts and with similar age and gender distributions of the probands with ADHD.

You may not qualify if:

  • The proband subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with blood withdrawal or neuropsychological assessments.
  • The control subjects will be excluded from the study if they currently meet criteria or have a history of the following condition as defined by DSM-IV: Schizophrenia, Schizoaffective Disorder, Organic Psychosis, or Pervasive Developmental Disorder. Moreover, the subjects will also be excluded from the study if they completely cannot cooperate with neuropsychological assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan Univeristy Hospital

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

The subjects will receive blood withdrawal. The blood sample will be used for establishing lymphoblastoid cell lines, which will be used for molecular genetic experiments.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Susan Shur-Fen Gau, MD, PhD

    National Taiwan University Hospital & College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2010

First Posted

January 20, 2010

Study Start

August 1, 2010

Primary Completion

July 31, 2013

Study Completion

July 31, 2013

Last Updated

September 5, 2021

Record last verified: 2021-09

Locations