Biomarkers that predict medication-related side effects in children with ADHD
Official title: A Multimodal Neurobiological Investigation of Biomarkers Predicting Medication-Induced Adverse Effects in Children With Attention-Deficit/Hyperactivity Disorder
Run by National Taiwan University Hospital · NCT07900451 · Data updated 2026-11-12
This study tests whether combined brain, cognitive, and metabolite markers can predict side effects from methylphenidate in kids with ADHD.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 6 Years to 16 Years |
| Sex | All |
| Enrollment | 90 (estimated) |
| Sponsor | National Taiwan University Hospital Academic / other |
| Locations | 1 site (Taipei, Taiwan) |
| Status | Recruiting |
| Started | August 1, 2026 |
| Main results expected | July 31, 2029 |
| Study ends | July 31, 2029 |
| Registry record updated | October 28, 2026 |
| Trial ID | NCT07900451 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Children aged 6–16 who meet DSM-5 criteria for ADHD, have CGI-ADHD-S > 3, and FSIQ > 80.
✕Probably not a fit
Children with comorbid major psychiatric or neurological illnesses, serious medical conditions, prior ADHD pharmacotherapy, or those outside the age range may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to create a multimodal model by integrating neuropsychological testing, neurophysiological data, and metabolomic measurements to identify biomarkers that predict adverse effects from methylphenidate in children aged 6 to 16 with ADHD. Participants will be evaluated at baseline and monitored for adverse effects as they undergo methylphenidate treatment. The goal is to support individualized risk assessment and inform clinical decision-making. Exclusion criteria restrict major psychiatric, neurological, and systemic medical conditions, as well as prior ADHD pharmacotherapy exposure. The study is conducted at National Taiwan University Hospital in Taipei, led by NTUH with no listed collaborators.
Why it matters
Potential benefit: If successful, the model could help clinicians predict which children are at higher risk for methylphenidate-related adverse effects and tailor treatment accordingly.
How similar studies have gone: Prior work in biomarker-based prediction is emerging, but multisystem multimodal approaches in pediatric ADHD treatment remain relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. 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.
Where it's running
-
National Taiwan University Hospital
Taipei, Taiwan, Taiwan Recruiting
Study contacts
- Study coordinator: Chi-Yung Shang, MD, PhD
- Email: cyshang@ntu.edu.tw
- Phone: +886-2-23123456
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.