Attention Deficit Hyperactivity DisorderNCT01247610
Adult Outcome of Children With 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
Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%), early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high heritability. Read more about this study
- Who is it for?
- Ages 17 to 24 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- How many people
- 390 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2011to 31 Dec 2015
- 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 17 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The sample will consist of (1) 217 adolescents (180 males, 83%) who were diagnosed of ADHD at childhood and followed up by Gau and consented to this follow-up study, and (2) 173 healthy controls (123, Males, 71%) without lifetime ADHD to late adolescence and adulthood. This cohort was established from 2005 to 2008. We will invite them for complete assessments 6 years after their assessments at adolescence according to the original assessment schedules from 2005-2008. The estimated age ranges are 17-24 years old.
Who may be able to join
- Persistent ADHD combined type (Group 1, n=30): Subjects who have persistent diagnosis of ADHD, combined type, at adulthood according to the DSM-IV diagnostic criteria and who have same-sex unaffected siblings are included. If more than 30 subjects meet the inclusion criteria, the subjects with more severe ADHD symptoms based on the ASRS and K-SADS ratings will be included.
- Unaffected sibling (Group 2, n=30): The same sex and handedness unaffected siblings of Group 1 will be recruited. They need to be re-assessed by psychiatric interview to confirm no lifetime diagnosis of ADHD.
- Good response to MPH (Group 3, n=30): Subjects whose ADHD symptoms meet the DSM-IV symptom criteria at adulthood and who either have DAT1 genes (around 10% of Taiwanese children with ADHD15) or demonstrate good response to MPH based on clinical interview were recruited for offand on-stimulant DSI and resting state fMRI assessments.
- Non-ADHD (Group 4, n=30): Among healthy controls without lifetime ADHD, the controls who do not have any lifetime psychiatric disorders and who do not have impaired neuropsychological function will be included. The control subjects will be matched for the age, gender, and handedness of Group 1.
Who cannot join
- These subjects will be excluded from the study if they have any of the following criteria: (1) Comorbidity with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; and (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment. In addition, if the control subjects have ODD or CD, they will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%), early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western studies in the past decade; however, there has been no such study in Asian countries. The ultimate goals of this longitudinal follow-up study are to investigate the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD) and their healthy controls at young adulthood as the primary aim; and to test whether structural and functional brain connectivity can be endophenotypes of ADHD, to localize the brain area that are corresponding to methylphenidate treatment effects, and to identify the genetic variants corresponding to the persistence of ADHD, treatment effect of methylphenidate, neurocognitive dysfunction, and structural and functional dysconnectivity in the brain as the secondary aims. With the accomplishment of these goals, this study will provide the first-hand data on adult ADHD in non-western countries, and will be one of few world-class studies on the topics of neurocognitive and imaging genomics on adult ADHD.
Read the detailed description
Primary specific aim:
To describe the manifestation and persistence of ADHD symptoms and to investigate the psychiatric, social, and executive functioning outcomes at young adulthood among children with ADHD;
Secondary specific aims
- To identify early individual (clinical, behavioral, and executive functioning and other neurocognitive variables), family, school, environmental factors to predict the symptom persistence and a wide-range of outcomes at young adulthood;
- To validate structural and functional connectivity of frontostriatal circuitry as imaging endophenotypes of ADHD by demonstrating that structural connectivity and functional connectivity of frontostriatal circuitry are altered in patients with ADHD and their unaffected siblings, are associated with ADHD symptoms, and are associated with genes related to dopamine neurotransmitter system;
- To identify brain area that is corresponding to the effect of methylphenidate; and
- To confirm reported candidate genes related to dopamine and noradrenergic neurotransmitter systems in the association with ADHD severity and subtypes (persistence, comorbidity, functional impairment, and treatment effects) and endophenotypes (executive function and structural and functional brain connectivity) such as DAT1, DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT.
The sample consists of a cohort of 217 young adults (180 males, 83%) who were diagnosed of ADHD at childhood and 173 healthy controls (123 males, 71%). At their ages of 17-24 (around 6 years after their assessments at adolescence), they will receive psychiatric interviews (ADHD+SADS, CAADID) to make the diagnosis of ADHD and other psychiatric disorders and blood sample collection. They will complete the following questionnaires: ASRS and CAARS-S:S for adult ADHD symptoms, TPQ for personality characteristics, ASRI-4 for DSM-IV psychopathology, AAQoL and WFIRS for social functions, and PBI for parenting styles; and perform the WAIS-III for current IQ and Cambridge Neuropsychological Test Automated Batteries for attention control and executive functioning. Among the cohort subjects, 30 subjects with persistent ADHD and their same-sex and -handedness unaffected siblings (n = 30), 30 ADHD subjects who have DAT1 and/or good response to methylphenidate (repeated MRI assessment one week later) based on clinical assessment, and 30 subjects without lifetime ADHD and any psychiatric disorder will receive diffusion spectrum imaging (DSI) and resting state functional MRI assessments (total number of MRI assessments, 150). We will genotype 3'VNTR of DAT1 gene and other candidate genes involving dopaminergic and adrenergic systems (DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT) for case-control association studies by using SNP and haplotype analysis.
We anticipate that this study (1) will provide the first prospective, longitudinal data of children with ADHD at late adolescence and young adulthood in Asian populations; (2) will be one of the first to establish a comprehensive, multi-dimensional dataset combining clinical, family, psychosocial, academic/vocational, neuropsychological, neuroimaging, and genetic data of young adults with ADHD. With the inclusion of imaging genetics data, the behavioral and neurocognitive phenotypes of ADHD can be validated, the imaging endophenotype can be tested, and image genetics approach may help identify genetic variants for ADHD.
- 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 | Not described | |
| Control group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2010 (estimated)
- Study start1 Jan 2011
- Primary completion31 Dec 2015
- Study completion31 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Other
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Principal investigator, National Taiwan University Hospital & College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01247610
- Sponsor's protocol ID
- 201003087R
- Status last verified
- Sep 2012
- First submitted
- 22 Nov 2010
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chiang HL, Chen YJ, Lin HY, Tseng WI, Gau SS. Disorder-Specific Alteration in White Matter Structural Property in Adults With Autism Spectrum Disorder Relative to Adults With ADHD and Adult Controls. Hum Brain Mapp. 2017 Jan;38(1):384-395. doi: 10.1002/hbm.23367. Epub 2016 Sep 15.
PubMed 27630075
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
- Adult Outcome of Children With Attention-deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01247610
- Acronym / sponsor ID
- 201003087R
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- National Health Research Institutes, Taiwan
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 31 Dec 2015 (actual)
- Study completion
- 31 Dec 2015 (actual)
- First posted
- 24 Nov 2010 (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.
Attention deficit/hyperactivity disorder (ADHD) has been recognized as a common (5-8%), early-onset, long-term impairing, heterogeneous neuropsychiatric disorder with high heritability. Due to its lifelong impairments up to adulthood, adult ADHD has drawn much more attention in Western studies in the past decade; however, there has been no such study in Asian countries. The ultimate goals of this longitudinal follow-up study are to investigate the outcomes of a cohort of children with attention-deficit/hyperactivity (ADHD) and their healthy controls at young adulthood as the primary aim; and to test whether structural and functional brain connectivity can be endophenotypes of ADHD, to localize the brain area that are corresponding to methylphenidate treatment effects, and to identify the genetic variants corresponding to the persistence of ADHD, treatment effect of methylphenidate, neurocognitive dysfunction, and structural and functional dysconnectivity in the brain as the secondary aims. With the accomplishment of these goals, this study will provide the first-hand data on adult ADHD in non-western countries, and will be one of few world-class studies on the topics of neurocognitive and imaging genomics on adult ADHD.
Detailed description
Primary specific aim:
To describe the manifestation and persistence of ADHD symptoms and to investigate the psychiatric, social, and executive functioning outcomes at young adulthood among children with ADHD;
Secondary specific aims
- To identify early individual (clinical, behavioral, and executive functioning and other neurocognitive variables), family, school, environmental factors to predict the symptom persistence and a wide-range of outcomes at young adulthood;
- To validate structural and functional connectivity of frontostriatal circuitry as imaging endophenotypes of ADHD by demonstrating that structural connectivity and functional connectivity of frontostriatal circuitry are altered in patients with ADHD and their unaffected siblings, are associated with ADHD symptoms, and are associated with genes related to dopamine neurotransmitter system;
- To identify brain area that is corresponding to the effect of methylphenidate; and
- To confirm reported candidate genes related to dopamine and noradrenergic neurotransmitter systems in the association with ADHD severity and subtypes (persistence, comorbidity, functional impairment, and treatment effects) and endophenotypes (executive function and structural and functional brain connectivity) such as DAT1, DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT.
The sample consists of a cohort of 217 young adults (180 males, 83%) who were diagnosed of ADHD at childhood and 173 healthy controls (123 males, 71%). At their ages of 17-24 (around 6 years after their assessments at adolescence), they will receive psychiatric interviews (ADHD+SADS, CAADID) to make the diagnosis of ADHD and other psychiatric disorders and blood sample collection. They will complete the following questionnaires: ASRS and CAARS-S:S for adult ADHD symptoms, TPQ for personality characteristics, ASRI-4 for DSM-IV psychopathology, AAQoL and WFIRS for social functions, and PBI for parenting styles; and perform the WAIS-III for current IQ and Cambridge Neuropsychological Test Automated Batteries for attention control and executive functioning. Among the cohort subjects, 30 subjects with persistent ADHD and their same-sex and -handedness unaffected siblings (n = 30), 30 ADHD subjects who have DAT1 and/or good response to methylphenidate (repeated MRI assessment one week later) based on clinical assessment, and 30 subjects without lifetime ADHD and any psychiatric disorder will receive diffusion spectrum imaging (DSI) and resting state functional MRI assessments (total number of MRI assessments, 150). We will genotype 3'VNTR of DAT1 gene and other candidate genes involving dopaminergic and adrenergic systems (DRD4, MAO-A, ADRA2A, ADRA2C, NET, and COMT) for case-control association studies by using SNP and haplotype analysis.
We anticipate that this study (1) will provide the first prospective, longitudinal data of children with ADHD at late adolescence and young adulthood in Asian populations; (2) will be one of the first to establish a comprehensive, multi-dimensional dataset combining clinical, family, psychosocial, academic/vocational, neuropsychological, neuroimaging, and genetic data of young adults with ADHD. With the inclusion of imaging genetics data, the behavioral and neurocognitive phenotypes of ADHD can be validated, the imaging endophenotype can be tested, and image genetics approach may help identify genetic variants for ADHD.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD group | – | – |
| Control group | – | – |
Who may qualify
- Ages
- 17 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The sample will consist of (1) 217 adolescents (180 males, 83%) who were diagnosed of ADHD at childhood and followed up by Gau and consented to this follow-up study, and (2) 173 healthy controls (123, Males, 71%) without lifetime ADHD to late adolescence and adulthood. This cohort was established from 2005 to 2008. We will invite them for complete assessments 6 years after their assessments at adolescence according to the original assessment schedules from 2005-2008. The estimated age ranges are 17-24 years old.
Key inclusion criteria (4 listed)
- Persistent ADHD combined type (Group 1, n=30): Subjects who have persistent diagnosis of ADHD, combined type, at adulthood according to the DSM-IV diagnostic criteria and who have same-sex unaffected siblings are included. If more than 30 subjects meet the inclusion criteria, the subjects with more severe ADHD symptoms based on the ASRS and K-SADS ratings will be included.
- Unaffected sibling (Group 2, n=30): The same sex and handedness unaffected siblings of Group 1 will be recruited. They need to be re-assessed by psychiatric interview to confirm no lifetime diagnosis of ADHD.
- Good response to MPH (Group 3, n=30): Subjects whose ADHD symptoms meet the DSM-IV symptom criteria at adulthood and who either have DAT1 genes (around 10% of Taiwanese children with ADHD15) or demonstrate good response to MPH based on clinical interview were recruited for offand on-stimulant DSI and resting state fMRI assessments.
- Non-ADHD (Group 4, n=30): Among healthy controls without lifetime ADHD, the controls who do not have any lifetime psychiatric disorders and who do not have impaired neuropsychological function will be included. The control subjects will be matched for the age, gender, and handedness of Group 1.
Key exclusion criteria (1 listed)
- These subjects will be excluded from the study if they have any of the following criteria: (1) Comorbidity with DSM-IV-TR diagnosis of pervasive developmental disorder, schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorder, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital metabolic disorder, brain tumor, history of severe head trauma, and history of craniotomy; and (3)With visual or hearing impairments, or motor disability which may influence the process of MRI assessment. In addition, if the control subjects have ODD or CD, they will be 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
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.
- Derived from this study: PubMed 27630075Chiang HL, Chen YJ, Lin HY, Tseng WI, Gau SS. Disorder-Specific Alteration in White Matter Structural Property in Adults With Autism Spectrum Disorder Relative to Adults With ADHD and Adult Controls. Hum Brain Mapp. 2017 Jan;38(1):384-395. doi: 10.1002/hbm.23367. Epub 2016 Sep 15.
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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
National Taiwan University Hospital & College of Medicine
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 4 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 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?
On the ClinicalTrials.gov record for NCT01247610, which also lists 1 linked publication.
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.