Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT02710929 |
Other study ID # |
201412157RINA |
Secondary ID |
|
Status |
Completed |
Phase |
|
First received |
|
Last updated |
|
Start date |
August 1, 2015 |
Est. completion date |
July 31, 2018 |
Study information
Verified date |
September 2021 |
Source |
National Taiwan University Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
Specific Aims:
1. To find the genetic variations associated with spatial working memory performance in
patients with ADHD by using genome-wide association studies (GWAS);
2. To find the genetic variations associated with spatial working memory performance in
healthy subjects by using GWAS;
3. To recruit a validation sample and to replicate the findings from the initial GWAS;
4. To test whether genetic variations significantly associated with spatial working memory
are also associated with ADHD.
Description:
Attention deficit hyperactivity disorder (ADHD), characterized by inattention, hyperactivity
and impulsivity, is an early onset, highly heritable, clinically heterogeneous, long-term
impairing disorder with tremendous impact on individuals, families, and societies. Our
research team has conducted a series of biological studies on spatial working memory deficits
of ADHD, and substantial evidence has suggested spatial working memory deficits as the
important neuropsychological biomarker with translational values and favorable endophenotypic
properties for ADHD. Despite the abundance of molecular genetic studies on ADHD, the genetic
etiologies of ADHD have been non-conclusive. Because genetic studies on endophenotypes can
offer more information on genetic and brain process, endophenotypic approach can efficiently
enhance the statistical power and make genome-wide association studies (GWAS) applicable in
much smaller sample. To date, there has been no GWAS study on spatial working memory deficits
of ADHD.
This is a 3-year project. Our previous studies have collected blood samples and spatial
working memory data of 382 patients with ADHD and 150 healthy subjects. In this 3-year
project, we will recruit 232 healthy subjects, aged 7-18 years. The measures include (1)
interviews for psychopathology (K-SADS-E), (2) questionnaires to measures ADHD symptoms
(SNAP-IV), and (3) neuropsychological tests: Spatial Working Memory task of the CANTAB. In
the first year, a case-only GWAS on spatial working memory (n = 254) will be conducted. In
the second year, a control-only GWAS on spatial working memory (n = 254) will be conducted.
In the third year, findings from the initial two GWAS will be replicated in a validation
sample composed of 128 patients with ADHD and 128 healthy controls.
By careful calculation, a sample size of 382 ADHD subjects will provide adequate power to
detect genome-wide significant genetic variations and replicate the findings in an
independent validation sample. We anticipate to identify the relationship between genetic
variations of ADHD and the endophenotype of spatial working memory. Our findings will
significantly contribute to our understanding of the pathophysiological mechanisms of ADHD,
especially the pathological pathway from genes, through endophenotype, to behavioral
phenotypes.