Attention-deficit/Hyperactivity DisorderNCT02710929
A Genome-wide Association Study on the Endophenotype of Spatial Working Memory in ADHD
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention-deficit/Hyperactivity Disorder
- Type of treatment
- Injection or infusion
- How many people
- 232 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2015to 31 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The existing sample is composed of 382 children withADHD and 150 healthy subjects. We plan to recruit additional 232 healthy subjects (104 in the first year; 128 in the second year), aged 7 to 18 years.
Who may be able to join
- Subjects without any current or lifetime DSM-IV psychiatric disorders based on the K-SADS-E interviews.
Who cannot join
- Participants who had any past or current medical or neurological illness, who currently took psychotropic medication, or whose intelligence quotient (IQ) score was less than 80 were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Genome-wide Association Study on the Endophenotype of Spatial Working Memory in Attention Deficit Hyperactivity Disorder
Specific Aims:
- To find the genetic variations associated with spatial working memory performance in patients with ADHD by using genome-wide association studies (GWAS);
- To find the genetic variations associated with spatial working memory performance in healthy subjects by using GWAS;
- To recruit a validation sample and to replicate the findings from the initial GWAS;
- To test whether genetic variations significantly associated with spatial working memory are also associated with ADHD.
Read the detailed 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.
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD group | Subjects with clinical diagnosis of ADHD according to the DSM-IV criteria | |
| TD group | Typically development controls without lifetime diagnosis with ADHD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric interview
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
Measured: 1 hour
Secondary outcomes (1)
Spatial working memory
Subjects will be assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2016 (estimated)
- Study start1 Aug 2015
- Primary completion31 Jul 2018
- Study completion31 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 232 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi-Yung Shang, MD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02710929
- Sponsor's protocol ID
- 201412157RINA
- Status last verified
- Sep 2021
- First submitted
- 13 Mar 2016
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Genome-wide Association Study on the Endophenotype of Spatial Working Memory in Attention Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02710929
- Acronym / sponsor ID
- 201412157RINA
- Conditions
- Attention-deficit/Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 232 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Jul 2018 (actual)
- First posted
- 17 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aims:
- To find the genetic variations associated with spatial working memory performance in patients with ADHD by using genome-wide association studies (GWAS);
- To find the genetic variations associated with spatial working memory performance in healthy subjects by using GWAS;
- To recruit a validation sample and to replicate the findings from the initial GWAS;
- To test whether genetic variations significantly associated with spatial working memory are also associated with ADHD.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | –Subjects with clinical diagnosis of ADHD according to the DSM-IV criteria |
| TD group | – | –Typically development controls without lifetime diagnosis with ADHD |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The existing sample is composed of 382 children withADHD and 150 healthy subjects. We plan to recruit additional 232 healthy subjects (104 in the first year; 128 in the second year), aged 7 to 18 years.
Key inclusion criteria (1 listed)
- Subjects without any current or lifetime DSM-IV psychiatric disorders based on the K-SADS-E interviews.
Key exclusion criteria (1 listed)
- Participants who had any past or current medical or neurological illness, who currently took psychotropic medication, or whose intelligence quotient (IQ) score was less than 80 were excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Psychiatric interview
Time frame: 1 hour
Subjects will be interviewed by Chinese Version of the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E)
1 secondary outcome
Spatial working memory
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Attention-deficit/Hyperactivity Disorder
Not yet recruiting
Cognitive-Motor Training With the DextEgg in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Digital Therapeutics for Behavior Problems
Problem Behavior, Child Behavior
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Acupuncture for ADHD: Acupoint Data Mining, Clinical Effectiveness, and Interviews to Explore Treatment Outcomes.
Acupuncture, ADHD - Attention Deficit Disorder With Hyperactivity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi-Yung Shang, MD principal investigator
Dept of Psychiatry, National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention-deficit/Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychiatric interview (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.