Monoamine Transporter GenesNCT04571125
Multimodal Neurobiological Approaches to Explore the Gene-Environment Interactions in ADHD
An observational study of Monoamine Transporter Genes and Environmental Factors, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
Previous studies have demonstrated significant associations of attention-deficit hyperactivity disorder (ADHD) with monoamine transporter genes, including dopamine transporter gene (DAT1), norepinephrine transporter gene (SLC6A2), and serotonin transporter gene (SLC6A4) as well as the important role of environmental… Read more about this study
- Who is it for?
- Ages 7 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Monoamine Transporter Genes, Environmental Factors
- How many people
- 202 participants
- Where
- 2 sitesTaiwan
- Study dates
- 19 Sep 2020to 5 Jul 2023
- 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 16 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: 120 drug-naïve patients with ADHD, aged 7-16, and 120 age- and sex-matched typically developing controls will be recruited in this project.
Who may be able to join
- Children or adolescents, between 7 and 16 years of age, must have clinical diagnosis of ADHD according to the DSM-5 diagnostic criteria.
- They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
- They and their parents must understand sufficiently to communicate properly with the investigators.
- They must have a Full-Scale Intelligence Quotient(FIQ) score greater than 80.
Who cannot join
- They have a major psychiatric comorbid disorder, including schizophrenia, schizoaffective disorder, affective disorders, or autism spectrum disorder.
- They have a past history of seizure, or they are taking antiepileptic drugs.
- They have a past history of substance dependence or abuse, including nicotine, alcohol, amphetamine, or any over-the-counter medication.
- They have a past history of major systemic disease.
- They are using Chinese herbs or health supplements.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei, 110
college of Medicine, National Taiwan University
Taipei
About this study
Official title: A Study With Multimodal Neurobiological Approaches to Explore the Interactions Between Monoamine Transporter Genes and Environmental Factors on Attention Deficit Hyperactivity Disorder.
Previous studies have demonstrated significant associations of attention-deficit hyperactivity disorder (ADHD) with monoamine transporter genes, including dopamine transporter gene (DAT1), norepinephrine transporter gene (SLC6A2), and serotonin transporter gene (SLC6A4) as well as the important role of environmental factors in the pathogenesis of ADHD. Hence, investigating how genes and environments interact with each other may contribute to the understanding of the pathophysiological mechanisms of ADHD. In this 3-year project, investigators will explore the complex gene-environment interplay in ADHD with multimodal neurobiological approaches, including neuropsychology, neuroimaging, and metabolites, in order to identify the crucial pathophysiological pathways from genes to the brain.
Read the detailed description
In the present project, investigators aim to explore the complex gene-environment interplay in children with ADHD to identify the crucial pathophysiological pathways from genes to the brain. To achieve our objective, investigators will use multimodal neurobiological approaches to effectively resolve the four major challenges in exploring gene-environment interactions on ADHD.
- investigators will use multiple levels of neurobiological approaches to identify the interactions between monoamine transporter genes and environment on ADHD, including neuropsychology, neuroimaging, and neuroactive metabolites in plasma, which will provide larger effects than clinical diagnosis.
- investigators will employ correlation analyses to test for the presence of correlations between the monoamine transporter genotypes and the environmental factors.
- investigators will use both categorical (diagnosis of ADHD) and dimensional (inattention and hyperactivity-impulsivity symptoms of ADHD) approaches to assess the interaction effects between monoamine transporter genes and environment.
- investigators will conduct interactions with ageitems to model more accurately the effects of age, which may be non-linearly related to the neurobiological basis of ADHD.
- Conditions
- Monoamine Transporter Genes, Environmental Factors
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-V 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.
ADHD symptoms
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 (4)
Neuropsychological testing
Subjects will be assessed by the Cambridge Neuropsychological Test Automated Battery (CANTAB)
Measured: 1.5 hours
Neuropsychological testing
Subjects will be assessed by the Continuous Performance Test
Measured: 15 mins
Metabolomics profiling
All the biomarkers are relative ratios. Although all the names of metabolites examined in this study cannot be listed due to the upper limitation of word number (999 characters), the metabolomics profiling includes Hydroxybutyric acid, Undecanedicarboxylic acid, Methyladenosine, Hydroxybutyric acid, Furoylglycine, Hydroxy, Hydroxybutyric acid, Hydroxycaproic acid,Oxoglutarate, Hydroxyisovaleric acid, Hydroxymethylglutaric acid,Indolepropionic acid, Methyladenine, Methylhistidine, Methylindole, Methylxanthine, Pyridylacetic acid, Guanidinobutanoic acid, Dihydrothymine, Aminolevulinic acid, Dodecenoic acid, Hydroxylysine P66-59, Methylcytidine, Acetoacetic acid, Acrylamide, Allose, AMP, Androstenedione, Aspartic acid, Betaine, Bradykinin, Carnitine, Cholic Acid, cis-Aconitate, cis-Fenpropimorph, citric acid, Corticosterone, Creatine, Creatinine, D-Arginine, Decanoylcarnitine, Dehydroascorbic acid, Deoxycholic acid, Deoxyribose, etc.
Measured: 10 mins
Brain imaging
Subjects will be assessed by structural and functional brain imaging, including xoxel-based morphometry, diffusion spectrum imaging, resting-state fMRI, and counting Stroop task fMRI
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 posted30 Sep 2020
- Study start19 Sep 2020
- Primary completion5 Jul 2023
- Study completion5 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoamine Transporter GenesStudies 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
- 202 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Susan Shur-Fen Gau, MD, PhD, Study director, Department of Psychiatry, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04571125
- Sponsor's protocol ID
- 201912085RINA
- Status last verified
- Jun 2023
- First submitted
- 27 Aug 2020
- Last updated
- 19 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study With Multimodal Neurobiological Approaches to Explore the Interactions Between Monoamine Transporter Genes and Environmental Factors on Attention Deficit Hyperactivity Disorder.
- ClinicalTrials.gov ID
- NCT04571125
- Acronym / sponsor ID
- 201912085RINA
- Conditions
- Monoamine Transporter Genes, Environmental Factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 202 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 5 Jul 2023 (actual)
- Study completion
- 5 Jul 2023 (actual)
- First posted
- 30 Sep 2020 (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.
Previous studies have demonstrated significant associations of attention-deficit hyperactivity disorder (ADHD) with monoamine transporter genes, including dopamine transporter gene (DAT1), norepinephrine transporter gene (SLC6A2), and serotonin transporter gene (SLC6A4) as well as the important role of environmental factors in the pathogenesis of ADHD. Hence, investigating how genes and environments interact with each other may contribute to the understanding of the pathophysiological mechanisms of ADHD. In this 3-year project, investigators will explore the complex gene-environment interplay in ADHD with multimodal neurobiological approaches, including neuropsychology, neuroimaging, and metabolites, in order to identify the crucial pathophysiological pathways from genes to the brain.
Detailed description
In the present project, investigators aim to explore the complex gene-environment interplay in children with ADHD to identify the crucial pathophysiological pathways from genes to the brain. To achieve our objective, investigators will use multimodal neurobiological approaches to effectively resolve the four major challenges in exploring gene-environment interactions on ADHD.
- investigators will use multiple levels of neurobiological approaches to identify the interactions between monoamine transporter genes and environment on ADHD, including neuropsychology, neuroimaging, and neuroactive metabolites in plasma, which will provide larger effects than clinical diagnosis.
- investigators will employ correlation analyses to test for the presence of correlations between the monoamine transporter genotypes and the environmental factors.
- investigators will use both categorical (diagnosis of ADHD) and dimensional (inattention and hyperactivity-impulsivity symptoms of ADHD) approaches to assess the interaction effects between monoamine transporter genes and environment.
- investigators will conduct interactions with ageitems to model more accurately the effects of age, which may be non-linearly related to the neurobiological basis of ADHD.
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-V criteria |
| TD GROUP | – | –Typically development controls without lifetime diagnosis with ADHD |
Who may qualify
- Ages
- 7 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- 120 drug-naïve patients with ADHD, aged 7-16, and 120 age- and sex-matched typically developing controls will be recruited in this project.
Key inclusion criteria (4 listed)
- Children or adolescents, between 7 and 16 years of age, must have clinical diagnosis of ADHD according to the DSM-5 diagnostic criteria.
- They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
- They and their parents must understand sufficiently to communicate properly with the investigators.
- They must have a Full-Scale Intelligence Quotient(FIQ) score greater than 80.
Key exclusion criteria (5 listed)
- They have a major psychiatric comorbid disorder, including schizophrenia, schizoaffective disorder, affective disorders, or autism spectrum disorder.
- They have a past history of seizure, or they are taking antiepileptic drugs.
- They have a past history of substance dependence or abuse, including nicotine, alcohol, amphetamine, or any over-the-counter medication.
- They have a past history of major systemic disease.
- They are using Chinese herbs or health supplements.
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
ADHD symptoms
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)
4 secondary outcomes
Neuropsychological testing
Time frame: 1.5 hours
Neuropsychological testing
Time frame: 15 mins
Metabolomics profiling
Time frame: 10 mins
Brain imaging
Time frame: 1 hour
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 19 Mar 2024.
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 study director
Department of Psychiatry, National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Monoamine Transporter Genes and Environmental Factors, run by National Taiwan University Hospital at 2 sites 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 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
ADHD symptoms (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 19 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.