ADHDNCT07900451
Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD
An observational study of ADHD, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To build a multimodal model combining neuropsychological, neurophysiological, and metabolomic measures to identify biomarkers predicting MPH-induced adverse effects and their underlying mechanisms, supporting individualized risk assessment in clinical practice. Read more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- ADHD
- What is being tested?
- methylphenidate
- How many people
- 90 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2026to 31 Jul 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: 90 medication-naïve children with ADHD aged 6 to 16 years will be recruited in this project.
Who may be able to join
- Participants, between the ages of 6 and 16 must meet the DSM-5 criteria for ADHD.
- At the time of initial evaluation, participants must exhibit a score greater than 3 on the Clinical Global Impressions scale for ADHD Severity (CGI-ADHD-S).
- Cognitive assessment of participants must demonstrate a Full-Scale Intelligence Quotient (FSIQ) greater than 80.
Who cannot join
- Individuals with comorbid major psychiatric disorders-including autism spectrum disorder (ASD), psychotic disorders, mood disorders, or substance use disorders-will be excluded.
- Individuals with major neurological conditions, such as epilepsy or other central nervous system disorders, will be excluded.
- Individuals with serious systemic medical conditions, including diabetes mellitus or cardiovascular disease, will be excluded.
- Individuals with any prior exposure to pharmacological treatments specifically intended for managing ADHD symptoms will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
National Taiwan University Hospital
Taipei, Taiwan, 110
Chi-Yung Shang, MD, PHD, 02-23123456 ext. 266965, cyshang@ntu.edu.tw
About this study
Official title: A Multimodal Neurobiological Investigation of Biomarkers Predicting Medication-Induced Adverse Effects in Children With Attention-Deficit/Hyperactivity Disorder
To build a multimodal model combining neuropsychological, neurophysiological, and metabolomic measures to identify biomarkers predicting MPH-induced adverse effects and their underlying mechanisms, supporting individualized risk assessment in clinical practice.
- Conditions
- ADHD
- Being tested
- methylphenidate
- 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.
methylphenidateDrug
The patients with ADHD will receive 16-week treatment with methylphenidate.
| Study group | Role | What they receive |
|---|---|---|
| ADHD GROUP | Subjects with clinical diagnosis of ADHD according to the DSM-V criteria Receives: Drug: methylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
Parents assisted in filling out the Barkley's Side Effects Rating Scale (SERS). Each question in this questionnaire is scaled from 0 to 9. The higher the score on each question, the more severe the symptom.
Measured: 5 minutes
Diagnostic interview
We will interview all the participants and their parents to examine whether the participants have any psychiatric disorder by employing the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E).
Measured: 1 hour
ADHD symptoms
Subjects will be interviewed by ADHD rating scale , which consists of 18 items to measure the symptomatology of ADHD . Each question in this questionnaire is scaled from 0 to 3. The higher the total score, the more severe the symptoms.
Measured: 15 minutes
Secondary outcomes (7)
Neurobiological assessments
Resting state EEG will be recorded in NTUH ERP lab. The EEG will be processed for functional connectivity indices between regions are calculated using the magnitude squared coherence (Coh) in the delta(delta)/theta(theta)/alpha(alpha)/beta(beta) frequency bands and the nonlinear index (L) of generalized synchronization.
Measured: 10 minutes
Neurobiological assessments
Resting state EEG will be recorded in NTUH ERP lab. Phase transfer entropy (PTE) will be used to construct the effective connectivity. The topological properties of networks and flow gain are measured separately in four bands (delta, theta, alpha, and beta).
Measured: 10 minutes
Neurobiological assessments
Resting state EEG will be recorded in NTUH ERP lab. We will perform Fast Fourier Transform using the pwelch algorithm, with a 128 sample triangular window, to obtain time-frequency domain measures. Mean spectral estimates in various power bands are computed. As a measure of intraindividual variability in neural activity, the standard deviation of the power in each 2-second trial is calculated for each band for each participant.
Measured: 10 minutes
Neurobiological assessments
Auditory MMN/P3a (task-free ERP) will be recorded in NTUH ERP.
Measured: 30 minutes
Neurobiological assessments
dichotic continuous performance task(DCPT, task-related ERP modified from Conner's CATA) will be recorded in NTUH ERP lab.
Measured: 20 minutes
liquid chromatography-mass spectrometry
Whole blood samples will be collected after 8 hours of fasting. The investigators will employ liquid chromatography coupled to mass spectrometry (LC/MS) to conduct the experiments of metabolomic profiling of the serum at the Metabolomics Core Laboratory, National Taiwan University.
Measured: 5 minutes
Neuropsychological testing
Subjects will be assessed by the WISC-V(Wechsler Intelligence Scale for Children),WISC-V scores between 90 and 109 represent moderate general intelligence, and higher scores represent relatively better cognitive function.
Measured: 1.5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2026
- Study start1 Aug 2026
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
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
- NCT07900451
- Sponsor's protocol ID
- 202512119RINA
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 28 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multimodal Neurobiological Investigation of Biomarkers Predicting Medication-Induced Adverse Effects in Children With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT07900451
- Acronym / sponsor ID
- 202512119RINA
- Conditions
- ADHD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2026 (actual)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 28 Oct 2026 (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.
To build a multimodal model combining neuropsychological, neurophysiological, and metabolomic measures to identify biomarkers predicting MPH-induced adverse effects and their underlying mechanisms, supporting individualized risk assessment in clinical practice.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ADHD GROUP | – | Drug: methylphenidateSubjects with clinical diagnosis of ADHD according to the DSM-V criteria |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- 90 medication-naïve children with ADHD aged 6 to 16 years will be recruited in this project.
Key inclusion criteria (3 listed)
- Participants, between the ages of 6 and 16 must meet the DSM-5 criteria for ADHD.
- At the time of initial evaluation, participants must exhibit a score greater than 3 on the Clinical Global Impressions scale for ADHD Severity (CGI-ADHD-S).
- Cognitive assessment of participants must demonstrate a Full-Scale Intelligence Quotient (FSIQ) greater than 80.
Key exclusion criteria (4 listed)
- Individuals with comorbid major psychiatric disorders-including autism spectrum disorder (ASD), psychotic disorders, mood disorders, or substance use disorders-will be excluded.
- Individuals with major neurological conditions, such as epilepsy or other central nervous system disorders, will be excluded.
- Individuals with serious systemic medical conditions, including diabetes mellitus or cardiovascular disease, will be excluded.
- Individuals with any prior exposure to pharmacological treatments specifically intended for managing ADHD symptoms 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylphenidateThe patients with ADHD will receive 16-week treatment with methylphenidate. | Drug | ADHD GROUP |
Primary outcome
Questionnaire
Time frame: 5 minutes
Parents assisted in filling out the Barkley's Side Effects Rating Scale (SERS). Each question in this questionnaire is scaled from 0 to 9. The higher the score on each question, the more severe the symptom.
Diagnostic interview
Time frame: 1 hour
We will interview all the participants and their parents to examine whether the participants have any psychiatric disorder by employing the Kiddie Epidemiologic version of the Schedule for Affective Disorders and Schizophrenia (K-SADS-E).
ADHD symptoms
Time frame: 15 minutes
Subjects will be interviewed by ADHD rating scale , which consists of 18 items to measure the symptomatology of ADHD . Each question in this questionnaire is scaled from 0 to 3. The higher the total score, the more severe the symptoms.
7 secondary outcomes
Neurobiological assessments
Time frame: 10 minutes
Neurobiological assessments
Time frame: 10 minutes
Neurobiological assessments
Time frame: 10 minutes
Neurobiological assessments
Time frame: 30 minutes
Neurobiological assessments
Time frame: 20 minutes
liquid chromatography-mass spectrometry
Time frame: 5 minutes
Neuropsychological testing
Time frame: 1.5 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
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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.
Susan Shur-Fen Gau, MD, PhD study director
Department 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 ADHD, 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Yung Shang, MD, PhD (+886-2-23123456 ext. 66965, cyshang@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Questionnaire (time frame: 5 minutes). The study lists 3 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 28 Oct 2026.