Attention Deficit Hyperactivity DisorderNCT00756158
Molecular Studies on the Candidate Genes of Dopaminergic and Noradrenergic Systems in ADHD
An observational study of Attention Deficit Hyperactivity Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The ultimate goal of this study is to find specific polymorphism of candidate genes associated with endophenotypes and/or phenomenological phenotypes of ADHD. We propose to replicate the analysis of the candidate genes identified by previous genetic studies on ADHD using the candidate gene association study design… 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
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2008to 31 Jul 2011
- 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 100 probands with ADHD, aged 7-18. Their biological parents (n = 200) and siblings (estimated number = 75) born to the same biological parents will be recruited as the parent controls and sibling controls, respectively, for the family-based case control study.
Who may be able to join
- The inclusion criteria for the proband subjects are
- That subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder 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;
- Their ages range from 7 to 18 when we conduct the study;
- Subjects have at least one biological parent;
- Both parents are Han Chinese;
- 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:
- 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, collection of saliva, or buccal swabs.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Molecular Studies on the Candidate Genes of Dopaminergic and Noradrenergic Systems in Attention-deficit Hyperactivity Disorder
The ultimate goal of this study is to find specific polymorphism of candidate genes associated with endophenotypes and/or phenomenological phenotypes of ADHD. 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. These results will lead our team: (1) to resolve controversies over inconsistent findings in previous genetic studies and contribute to the literature on the validity of ASD using clinical and genetic data; (2) to study the pathogenetic process of abnormal genes in abnormal neuropsychological and neurobiological functions of ADHD; (3) to delineate the nature and the effect of gene-gene interaction in the etiology of 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. 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, neuropsychological deficits, and genetic variants for ADHD in Chinese population. This present study, a family-based parental control association study, aims to identify the genetic markers of dopaminergic and noradrenergic systems for ADHD using the dichotomous categorization of affected and non-affected, quantitative phenotypes (symptom dimension and severity of ADHD) and endophenotype (neuropsychological measures) as well.
Specific Aims:
- to determine the components of ADHD and neuropsychological deficits with the greatest familial recurrence risks;
- to replicate studies with positive genetic findings from literature by performing candidate gene analysis such as DRD4, DRD2, DRD5, DAT1, DBH, ADRA2C, ADRA1C, and SLC6A2;
- to identify the potential genetic variants using haplotype tagSNPs for the following candidate genes, MAO-A and ADRA2A and any updated genetic findings.
In addition to a sample of 200 ADHD families (200 probands, 400 parents, and 150 siblings) being recruited in a parallel study (NSC96-2628-B-002-069 -MY3), we will recruit another 100 probands with ADHD, aged 7-18, and their parents (n = 200) and siblings (n= 75) in this project. The phenotype measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (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 300 ADHD families (200 in NSC96-2628-B-002-069-MY3 and 100 in this project), 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 and pharmacogenetic study on ADHD.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, dopaminergic, noradrenergic, 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 posted19 Sep 2008 (estimated)
- Study start1 Aug 2008
- Primary completion31 Jul 2011
- Study completion31 Jul 2011
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
- Family based
- Time perspective
- Other
- Enrolment
- 100 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
- Chi-Yung Shang, MD, Principal investigator, Dept of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00756158
- Sponsor's protocol ID
- 200712085R
- Status last verified
- Sep 2021
- First submitted
- 18 Sep 2008
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Studies on the Candidate Genes of Dopaminergic and Noradrenergic Systems in Attention-deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00756158
- Acronym / sponsor ID
- 200712085R
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, dopaminergic, noradrenergic, endophenotype, molecular genetics, candidate gene, Family-based Association study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 Aug 2008 (actual)
- Primary completion
- 31 Jul 2011 (actual)
- Study completion
- 31 Jul 2011 (actual)
- First posted
- 19 Sep 2008 (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 goal of this study is to find specific polymorphism of candidate genes associated with endophenotypes and/or phenomenological phenotypes of ADHD. 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. These results will lead our team: (1) to resolve controversies over inconsistent findings in previous genetic studies and contribute to the literature on the validity of ASD using clinical and genetic data; (2) to study the pathogenetic process of abnormal genes in abnormal neuropsychological and neurobiological functions of ADHD; (3) to delineate the nature and the effect of gene-gene interaction in the etiology of 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. 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, neuropsychological deficits, and genetic variants for ADHD in Chinese population. This present study, a family-based parental control association study, aims to identify the genetic markers of dopaminergic and noradrenergic systems for ADHD using the dichotomous categorization of affected and non-affected, quantitative phenotypes (symptom dimension and severity of ADHD) and endophenotype (neuropsychological measures) as well.
Specific Aims:
- to determine the components of ADHD and neuropsychological deficits with the greatest familial recurrence risks;
- to replicate studies with positive genetic findings from literature by performing candidate gene analysis such as DRD4, DRD2, DRD5, DAT1, DBH, ADRA2C, ADRA1C, and SLC6A2;
- to identify the potential genetic variants using haplotype tagSNPs for the following candidate genes, MAO-A and ADRA2A and any updated genetic findings.
In addition to a sample of 200 ADHD families (200 probands, 400 parents, and 150 siblings) being recruited in a parallel study (NSC96-2628-B-002-069 -MY3), we will recruit another 100 probands with ADHD, aged 7-18, and their parents (n = 200) and siblings (n= 75) in this project. The phenotype measures include (1) interviews for psychopathology (K-SADS-E) and social functioning (SAICA), (2) self-administered questionnaires to measures ADHD symptoms (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 300 ADHD families (200 in NSC96-2628-B-002-069-MY3 and 100 in this project), 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 and pharmacogenetic 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 100 probands with ADHD, aged 7-18. Their biological parents (n = 200) and siblings (estimated number = 75) born to the same biological parents will be recruited as the parent controls and sibling controls, respectively, for the family-based case control study.
Key inclusion criteria (6 listed)
- The inclusion criteria for the proband subjects are
- That subjects have a clinical diagnosis of ADHD, or Hyperkinetic Disorder 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;
- Their ages range from 7 to 18 when we conduct the study;
- Subjects have at least one biological parent;
- Both parents are Han Chinese;
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:
- 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 5 Sep 2021.
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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.
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 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 5 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.
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 5 Sep 2021.