Attention Deficit Hyperactivity DisorderNCT00529906
Endophenotype, Molecular Genetic Study on Attention-Deficit/Hyperactivity Disorder
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The ultimate goals of this study are to identify patterns of familial aggregation with regards to categorical and dimensional approaches of ADHD and neuropsychological measures, to validate the phenotypes and endophenotypes that are close to biological expression of genders underlying ADHD, and to identify the genetic… Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Dec 2010
- 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
- No healthy volunteers
- Child, Adult
Study population: The sample will consist of 200 children and adolescents with ADHD, aged 7-18.
Who may be able to join
- The inclusion criteria for the proband subjects are
- (1) that subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder (HD) defined by the DSM-IV and ICD-10, respectively, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits;
- (2) their ages range from 7 to 18 when we conduct the study;
- (3) subjects have at least one biological parent;
- (4) both parents are Han Chinese; and
- (5) subjects and their biological parents (and siblings if any) consent to participate in this study for complete phenotype assessments and blood withdraw or saliva collection for genetic study
Who cannot join
- 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:
- Shizophrenia,
- 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, collection of saliva, or buccal swabs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endophenotype, Molecular Genetic Study on Attention-deficit/ Hyperactivity Disorder
The ultimate goals of this study are to identify patterns of familial aggregation with regards to categorical and dimensional approaches of ADHD and neuropsychological measures, to validate the phenotypes and endophenotypes that are close to biological expression of genders underlying ADHD, and to identify the genetic variants close to the etiological genes of ADHD in Taiwanese sample. We propose to replicate the analysis of the candidate genes identified by previous genetic studies on ADHD using the candidate gene association study design (family-based case control study using parental controls) to validate the findings from other research groups. With the accomplishment of these goals, this study will resolve controversies over inconsistent findings in previous genetic studies and contribute to the literature on the validity of ASD using clinical and genetic data.
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. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults. Neuropsychological deficits related to executive functions, state regulation, and delay aversion show heritability, replicated association with ADHD, and familial-genetic overlap with ADHD, are suitable for biomarkers for ADHD. Despite the abundance of molecular genetic studies on ADHD, the genetic etiologies of ADHD have been non-conclusive, and there is limited information about the expressions, endophenotypes, and genetic variants for ADHD in Chinese population. This polite study, a family-based parental control association study, aims to identify the genetic markers for ADHD using the dichotomous categorization of affected and non-affected, quantitative phenotypes (symptoms dimension and severity of ADHD) and endophenotype (neuropsychological measures) as well.
Specific Aims:
- to determine the components of ADHD and neuropsychological deficit with the greatest familial recurrence risks;
- to replicate studies with positive genetic findings from literature by performing candidate gene analysis such as DRD4, DAT1, DRD5, HTR1B, SNPA-25, 5-HTT, DBH, CHRNA4, CHRNA7 etc;
- to identify the potential genetic variants using haplotype tag SNPs for the following candidate genes, CHRNA4 and CHRNA7 and any updated genetic findings.
We will recruit 200 probands with ADHD, aged 7-18, and their parents (n = 400) and siblings (n= 150) in three years (50, 100, and 50 families with ADHD in the 1st, 2nd, and 3rd year, respectively). The measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (CPRS-R:S, CTRS-R:S, SNAP-IV and Adult ADHD rating scale) and comorbid conditions (ASRI and CBCL), and (3) Neuropsychological tests: WISC-III, CPT, CANTAB, and Time Perception Tasks. The DNA will be collected and analyzed. The transmission/disequilibrium test (TDT) and quantitative TDT will be used in data analysis.
We anticipate the establishment of clinical, neuropsychological, and genetic database of 200 ADHD families, completion of the screening of several candidate genes, and identification of potential genetic variants for ADHD, and determination of their association with ADHD diagnosis and symptoms and its endophenotype in a Taiwanese sample. The long-term objectives are to identify the behavioral phenotypes and endophenotypes that are close to the biological expression of genes underlying ADHD. The findings of different approaches to identify the genetic etiologies for ADHD in this pilot study should help us to determine the most promising approach for future molecular genetic study on ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, neuropsychological deficits, endophenotype, molecular genetics, candidate gene, family-based association study
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2007 (estimated)
- Study startAug 2007
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Family based
- Time perspective
- Other
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529906
- Sponsor's protocol ID
- 200612114R
- Status last verified
- Dec 2009
- First submitted
- 13 Sep 2007
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiang HL, Gau SS. Impact of executive functions on school and peer functions in youths with ADHD. Res Dev Disabil. 2014 May;35(5):963-72. doi: 10.1016/j.ridd.2014.02.010. Epub 2014 Mar 11.
PubMed 24636025Gau SS, Chiang HL. Association between early attention-deficit/hyperactivity symptoms and current verbal and visuo-spatial short-term memory. Res Dev Disabil. 2013 Jan;34(1):710-20. doi: 10.1016/j.ridd.2012.10.005. Epub 2012 Nov 5.
PubMed 23137723
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endophenotype, Molecular Genetic Study on Attention-deficit/ Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00529906
- Acronym / sponsor ID
- 200612114R
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- attention deficit hyperactivity disorder, neuropsychological deficits, endophenotype, molecular genetics, candidate gene, family-based association study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Sep 2007 (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.
The ultimate goals of this study are to identify patterns of familial aggregation with regards to categorical and dimensional approaches of ADHD and neuropsychological measures, to validate the phenotypes and endophenotypes that are close to biological expression of genders underlying ADHD, and to identify the genetic variants close to the etiological genes of ADHD in Taiwanese sample. We propose to replicate the analysis of the candidate genes identified by previous genetic studies on ADHD using the candidate gene association study design (family-based case control study using parental controls) to validate the findings from other research groups. With the accomplishment of these goals, this study will resolve controversies over inconsistent findings in previous genetic studies and contribute to the literature on the validity of ASD using clinical and genetic data.
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. It affects 5-10% of school-aged children worldwide (7.5% in Taiwan) and 2-4% of adults. Neuropsychological deficits related to executive functions, state regulation, and delay aversion show heritability, replicated association with ADHD, and familial-genetic overlap with ADHD, are suitable for biomarkers for ADHD. Despite the abundance of molecular genetic studies on ADHD, the genetic etiologies of ADHD have been non-conclusive, and there is limited information about the expressions, endophenotypes, and genetic variants for ADHD in Chinese population. This polite study, a family-based parental control association study, aims to identify the genetic markers for ADHD using the dichotomous categorization of affected and non-affected, quantitative phenotypes (symptoms dimension and severity of ADHD) and endophenotype (neuropsychological measures) as well.
Specific Aims:
- to determine the components of ADHD and neuropsychological deficit with the greatest familial recurrence risks;
- to replicate studies with positive genetic findings from literature by performing candidate gene analysis such as DRD4, DAT1, DRD5, HTR1B, SNPA-25, 5-HTT, DBH, CHRNA4, CHRNA7 etc;
- to identify the potential genetic variants using haplotype tag SNPs for the following candidate genes, CHRNA4 and CHRNA7 and any updated genetic findings.
We will recruit 200 probands with ADHD, aged 7-18, and their parents (n = 400) and siblings (n= 150) in three years (50, 100, and 50 families with ADHD in the 1st, 2nd, and 3rd year, respectively). The measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (CPRS-R:S, CTRS-R:S, SNAP-IV and Adult ADHD rating scale) and comorbid conditions (ASRI and CBCL), and (3) Neuropsychological tests: WISC-III, CPT, CANTAB, and Time Perception Tasks. The DNA will be collected and analyzed. The transmission/disequilibrium test (TDT) and quantitative TDT will be used in data analysis.
We anticipate the establishment of clinical, neuropsychological, and genetic database of 200 ADHD families, completion of the screening of several candidate genes, and identification of potential genetic variants for ADHD, and determination of their association with ADHD diagnosis and symptoms and its endophenotype in a Taiwanese sample. The long-term objectives are to identify the behavioral phenotypes and endophenotypes that are close to the biological expression of genes underlying ADHD. The findings of different approaches to identify the genetic etiologies for ADHD in this pilot study should help us to determine the most promising approach for future molecular genetic study on ADHD.
Study design
- Observational model
- Family based
- Time perspective
- Other
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The sample will consist of 200 children and adolescents with ADHD, aged 7-18.
Key inclusion criteria (6 listed)
- The inclusion criteria for the proband subjects are
- (1) that subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder (HD) defined by the DSM-IV and ICD-10, respectively, which was made by a full-time board-certificated child psychiatrist at the first visit and following visits;
- (2) their ages range from 7 to 18 when we conduct the study;
- (3) subjects have at least one biological parent;
- (4) both parents are Han Chinese; and
Key exclusion criteria (5 listed)
- 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:
- Shizophrenia,
- 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, collection of saliva, or buccal swabs.
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
Not reported in the source record.
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 7 May 2021.
- Derived from this study: PubMed 24636025Chiang HL, Gau SS. Impact of executive functions on school and peer functions in youths with ADHD. Res Dev Disabil. 2014 May;35(5):963-72. doi: 10.1016/j.ridd.2014.02.010. Epub 2014 Mar 11.
- Derived from this study: PubMed 23137723Gau SS, Chiang HL. Association between early attention-deficit/hyperactivity symptoms and current verbal and visuo-spatial short-term memory. Res Dev Disabil. 2013 Jan;34(1):710-20. doi: 10.1016/j.ridd.2012.10.005. Epub 2012 Nov 5.
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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.
Susan Shur-Fen Gau, MD, PhD 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 6 inclusion and 5 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 7 May 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00529906, which also lists 2 linked publications.
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 7 May 2021.