Attention-Deficit Hyperactivity Disorder, Unspecified TypeNCT04878575
A Multi-dimensional Prospective Study to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders
An observational study of Attention-Deficit Hyperactivity Disorder, Unspecified Type and Autism Spectrum Disorder, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Attention-Deficit Hyperactivity Disorder, Unspecified Type, Autism Spectrum Disorder
- What is being tested?
- ASD diagnosis and Psychiatric diagnosis
- How many people
- 360 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2021to Dec 2025
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: 120 ASD and 120 ADHD, aged 4-18 will be recruited from the Department of Psychiatry, National Taiwan Univeristy Hospital(NTUH), or the participants with ASD or ADHD from Taiwan's National Epidemiological Study of Child Mental Disorders (TNESCMD). 120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders.
Who may be able to join
- Clinical diagnosis of autism spectrum disorder or attention-deficit hyperactivity disorder defined by the DSM-5 criteria, made by board-certificated child psychiatrists
- Ages range from 5 to 18
- Both parents are Han Chinese
- Subjects and their parents consented to have repeated assessments at 2 to 3 years later
Who cannot join
- Comorbidity with DSM-5 diagnoses of ADHD (TDC group), ASD (ADHD and TDC groups), schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use
- Comorbidity with neurological or systemic disorders
- Having a first degree relative who may have ASD based on family history method assessment (ADHD and TDC groups)
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan Univeristy Hospital
Taipei
Susan Shur-Fen Gau, MD, PhD, 886-2-23123456 ext. 66802, gaushufe@ntu.edu.tw
About this study
Official title: A Novel Multi-dimensional Prospective Study of the Gut-brain Axis Through Metabolic MRI, Metabolomics and Gut Microbiome to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders
This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.
Read the detailed description
Autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) are common neurodevelopmental disorders in Taiwan and worldwide (prevalence rate, ASD, 1%; ADHD, 3-10%), presenting as clinically and genetically heterogeneous disorders with early onset at childhood lasting to adulthood. Both disorders bring a tremendous impact on individuals, families, and society. Despite extensive studies on these two disorders, our knowledge about their pathogenetic mechanism is still minimal, and there are no biomarkers for effective prevention, early detection, diagnosis and biological treatment (ineffective in 30% ADHD patients, none for ASD). Although they have distinct symptom inclusion criteria and intervention, emerging evidence suggests that ASD and ADHD may share some genetic influences and susceptibility involving neuroanatomical phenotypes, cognitive deficits, and behavioral phenotypes. However, few studies have investigated these two disorders simultaneously. Moreover, the role of metabolomics and microbiome in neuropsychiatric disorders has drawn much attention recently. With the PI's long-term commitment to the neurocognitive/imaging/gene research ADHD and ASD in separate projects, our knowledge about these two disorders improved, but their underlying pathogenesis remains unclear. Hence, a multi-dimensional prospective gut-brain axis integration study highlighting the metabolism in the whole body to identify the common and unique factors of these two disorders and discover their gene-microenvironment interaction mechanism is extremely urgent and warranted.
Specific Aims:
- To identify and compare the early environmental factors (e.g., maternal, and pre-, peri-, and post-natal factors) affecting the gut- microbiome, cognition, and brain structures and functions among the ASD, ADHD and TDC groups at ages of 4-12 years old;
- To investigate the symptomatology, neuropsychology, neuroimaging, gut microbiome and metabolic biomarker signatures at Time 1 and Time 2 among the three groups while considering food, GI symptoms, and life style;
- To investigate the changes (Time2-Time1), stability, and interactions of the symptomatology, neuropsychology, neuroimaging (MRI+MRS), gut microbiome and metabolic biomarker signatures in youths with ASD and ADHD as compared to TDC over a 2-4-year follow-up period.
- To identify the predictors from the environmental (perinatal, food, lifestyle, family, school, neighborhood) and individual (behavior, gut microbiota, metabolomics, brain structure) factors for the neurocognitive/brain function and psychosocial outcomes in the follow-up.
- Being tested
- ASD diagnosis, Psychiatric diagnosis
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASD diagnosisOther
Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
Psychiatric diagnosisOther
Kiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5
| Study group | Role | What they receive |
|---|---|---|
| ASD group | 120 ASD patients (aged 5-18 years) Receives: Other: ASD diagnosis; Other: Psychiatric diagnosis | |
| ADHD group | 120 ADHD patients (aged 5-18 years) Receives: Other: Psychiatric diagnosis | |
| TDC group | 120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders Receives: Other: Psychiatric diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuropsychological functions: Continuous Performance Test(CPT)
The 4 dimensions of CPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
Measured: 15 minutes
Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
Measured: 1.5 hours
Structural neuroimaging: Diffusing spectrum imaging (DSI)
DSI is performed using a pulsed-gradient spin-echo diffusion echo planar imaging (EPI) sequence with 102 diffusion-encoding directions
Measured: 1 hour
Multi-echo resting-state fMRI (rfMRI)
rfMRI will be used to evaluate resting-state connectivity
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2021
- Study start1 Jan 2021
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention-Deficit Hyperactivity Disorder, Unspecified TypeStudies 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04878575
- Sponsor's protocol ID
- 201903105RINB
- Status last verified
- Oct 2023
- First submitted
- 4 May 2021
- Last updated
- 17 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Multi-dimensional Prospective Study of the Gut-brain Axis Through Metabolic MRI, Metabolomics and Gut Microbiome to Discover Gene-microenvironment Interactions in Neurodevelopmental Disorders
- ClinicalTrials.gov ID
- NCT04878575
- Acronym / sponsor ID
- 201903105RINB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 7 May 2021 (actual)
- 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.
This project is the first involving the two most common neurodevelopmental disorders, ASD and ADHD, as well as TDC to establish a multi-dimensional database (clinic, behavior, neurocognitive function, brain imaging, metabolomics, and microbiome) using the same methodology. Based on this integrated multi-dimensional databank, we anticipate exploring metabolic flows of the gut-brain axis during brain development and identifying the common and unique biomarkers of ASD and ADHD and high-risk materials related to their functions and the underlying mechanism. Moreover, distinguishing the characteristics of the gut microbiota, gastrointestinal disorders, and microbial flora dysbiosis also helps us, in turn, to accelerate the process of identifying biological treatments that can interfere or slow down the severity of cognitive impairments in neurodevelopmental disorders. Eventually, we anticipate finding the clinical and neurocognitive measures related to the direct or indirect influence of gut-brain signaling. Our findings are anticipated to improve the knowledge about neurodevelopmental disorders, enhance developing early detection, diagnosis, and treatment for ASD and ADHD, and contribute to precision medicine.
Detailed description
Autism spectrum disorder (ASD) and attention-deficit hyperactivity disorder (ADHD) are common neurodevelopmental disorders in Taiwan and worldwide (prevalence rate, ASD, 1%; ADHD, 3-10%), presenting as clinically and genetically heterogeneous disorders with early onset at childhood lasting to adulthood. Both disorders bring a tremendous impact on individuals, families, and society. Despite extensive studies on these two disorders, our knowledge about their pathogenetic mechanism is still minimal, and there are no biomarkers for effective prevention, early detection, diagnosis and biological treatment (ineffective in 30% ADHD patients, none for ASD). Although they have distinct symptom inclusion criteria and intervention, emerging evidence suggests that ASD and ADHD may share some genetic influences and susceptibility involving neuroanatomical phenotypes, cognitive deficits, and behavioral phenotypes. However, few studies have investigated these two disorders simultaneously. Moreover, the role of metabolomics and microbiome in neuropsychiatric disorders has drawn much attention recently. With the PI's long-term commitment to the neurocognitive/imaging/gene research ADHD and ASD in separate projects, our knowledge about these two disorders improved, but their underlying pathogenesis remains unclear. Hence, a multi-dimensional prospective gut-brain axis integration study highlighting the metabolism in the whole body to identify the common and unique factors of these two disorders and discover their gene-microenvironment interaction mechanism is extremely urgent and warranted.
Specific Aims:
- To identify and compare the early environmental factors (e.g., maternal, and pre-, peri-, and post-natal factors) affecting the gut- microbiome, cognition, and brain structures and functions among the ASD, ADHD and TDC groups at ages of 4-12 years old;
- To investigate the symptomatology, neuropsychology, neuroimaging, gut microbiome and metabolic biomarker signatures at Time 1 and Time 2 among the three groups while considering food, GI symptoms, and life style;
- To investigate the changes (Time2-Time1), stability, and interactions of the symptomatology, neuropsychology, neuroimaging (MRI+MRS), gut microbiome and metabolic biomarker signatures in youths with ASD and ADHD as compared to TDC over a 2-4-year follow-up period.
- To identify the predictors from the environmental (perinatal, food, lifestyle, family, school, neighborhood) and individual (behavior, gut microbiota, metabolomics, brain structure) factors for the neurocognitive/brain function and psychosocial outcomes in the follow-up.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ASD group | – | Other: ASD diagnosis, Other: Psychiatric diagnosis120 ASD patients (aged 5-18 years) |
| ADHD group | – | Other: Psychiatric diagnosis120 ADHD patients (aged 5-18 years) |
| TDC group | – | Other: Psychiatric diagnosis120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- 120 ASD and 120 ADHD, aged 4-18 will be recruited from the Department of Psychiatry, National Taiwan Univeristy Hospital(NTUH), or the participants with ASD or ADHD from Taiwan's National Epidemiological Study of Child Mental Disorders (TNESCMD). 120 age-, and sex-matched typically developing controls (TDC) will be recruited from the same geographic areas of the ASD/ADHD groups via referral by teachers or the invitation of participants without any psychiatric disorders.
Key inclusion criteria (4 listed)
- Clinical diagnosis of autism spectrum disorder or attention-deficit hyperactivity disorder defined by the DSM-5 criteria, made by board-certificated child psychiatrists
- Ages range from 5 to 18
- Both parents are Han Chinese
- Subjects and their parents consented to have repeated assessments at 2 to 3 years later
Key exclusion criteria (3 listed)
- Comorbidity with DSM-5 diagnoses of ADHD (TDC group), ASD (ADHD and TDC groups), schizophrenia, schizoaffective disorder, delusional disorder, other psychotic disorders, organic psychosis, schizotypal personality disorder, bipolar disorder, depression, severe anxiety disorders or substance use
- Comorbidity with neurological or systemic disorders
- Having a first degree relative who may have ASD based on family history method assessment (ADHD and TDC groups)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ASD diagnosisAutism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS) | Other | ASD group |
| Psychiatric diagnosisKiddie Schedule for Affective Disorders \& Schizophrenia (K-SADS) for DSM-5 | Other | ADHD group, ASD group, TDC group |
Primary outcome
Neuropsychological functions: Continuous Performance Test(CPT)
Time frame: 15 minutes
The 4 dimensions of CPT: focused attention, hyperactivity/impulsivity, sustained attention, and vigilance
Neuropsychological functions: Cambridge Neuropsychological Test Automated Batteries(CANTAB)
Time frame: 1.5 hours
The 4 main cognitive components of CANTAB: Visual Memory, Attention, Working and Planning Memory (Executive Functions), and Decision Making
Structural neuroimaging: Diffusing spectrum imaging (DSI)
Time frame: 1 hour
DSI is performed using a pulsed-gradient spin-echo diffusion echo planar imaging (EPI) sequence with 102 diffusion-encoding directions
Multi-echo resting-state fMRI (rfMRI)
Time frame: 1 hour
rfMRI will be used to evaluate resting-state connectivity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
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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.
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, Unspecified Type and Autism Spectrum 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 3 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuropsychological functions: Continuous Performance Test(CPT) (time frame: 15 minutes). The study lists 4 primary outcomes in all. 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 17 Oct 2023.