ClinicalTrials.gg
RecruitingNCT07900451Updated Oct 28, 2026

Multimodal Biomarkers Predicting Medication-Induced Adverse Effects in Children With ADHD

An observational study in ADHD, sponsored by National Taiwan University Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-10-28.

Sponsored by National Taiwan University Hospital · Observational

From the registry’s dates

  • Started Aug 2026; still recruiting 3 months later.
Updated Oct 28, 2026Newly registeredGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Attention Deficit Disorder with Hyperactivity

1,817 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 296 are open to participants now.

This study's planned enrollment of 90 is below the median of 127 across 329 observational studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

National Taiwan University Hospital is the lead sponsor of 2,615 studies on the registry; 576 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 2 (18%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

90 medication-naïve children with ADHD aged 6 to 16 years will be recruited in this project.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Participants, between the ages of 6 and 16 must meet the 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

DSM diagnostic criteria

The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (estimated)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • ADHD GROUP

    Subjects with clinical diagnosis of ADHD according to the DSM-V criteria

    Drug: methylphenidate

Interventions

  • The patients with ADHD will receive 16-week treatment with methylphenidate.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 minutes

  2. 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).

    Time frame: 1 hour

  3. 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.

    Time frame: 15 minutes

Secondary outcomes

  1. 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.

    Time frame: 10 minutes

  2. 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).

    Time frame: 10 minutes

  3. 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.

    Time frame: 10 minutes

  4. Neurobiological assessments

    Auditory MMN/P3a (task-free ERP) will be recorded in NTUH ERP.

    Time frame: 30 minutes

  5. Neurobiological assessments

    dichotic continuous performance task(DCPT, task-related ERP modified from Conner's CATA) will be recorded in NTUH ERP lab.

    Time frame: 20 minutes

  6. 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.

    Time frame: 5 minutes

  7. 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.

    Time frame: 1.5 hours

07

Study locations

1 of 1 sites recruiting
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2026 (actual). Primary completion is estimated for Jul 2029, 35 months after the start.

Of 85 non-industry observational studies under Attention Deficit Disorder with Hyperactivity, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 69. This study's planned 35 months is close to that.

Counting every sponsor, half of 95 studies reached it within 35 months; a quarter within 20 and three quarters within 69.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 21, 2026
First posted
Oct 28, 2026
StartActual
Aug 1, 2026
Primary completionEst.
Jul 31, 2029
CompletionEst.
Jul 31, 2029
Last update
Oct 28, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 28, 2026
Show all 1 update
  1. Oct 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07900451
Responsible party
Sponsor
First posted
Oct 28, 2026
Start date
Aug 1, 2026
Primary completion
Jul 31, 2029 (estimated)
Completion
Jul 31, 2029 (estimated)
Last update
Oct 28, 2026

Study contacts

Chi-Yung Shang, MD, PhD
Contact
cyshang@ntu.edu.tw
+886-2-23123456 ext. 66965
Susan Shur-Fen Gau, MD, PhD
study director · Department of Psychiatry, National Taiwan University Hospital

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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