Exploring how methylphenidate affects brain activity and metabolism in children with ADHD
Exploration of the Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With Attention-Deficit/Hyperactivity Disorder
National Taiwan University Hospital · NCT06073470
This study is testing how the medication methylphenidate affects brain activity and metabolism in children with ADHD to see if it can help improve their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 160 (estimated) |
| Ages | 6 Years to 18 Years |
| Sex | All |
| Sponsor | National Taiwan University Hospital (other) |
| Locations | 1 site (Taipei) |
| Trial ID | NCT06073470 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the relationship between changes in brain electrophysiology and metabolomics in children with ADHD undergoing treatment with methylphenidate. Over a 12-week period, the study will compare the effects of the medication on children diagnosed with ADHD against neurotypical controls. The goal is to identify biomarkers that can predict which children will respond positively to methylphenidate, as well as to understand the metabolic mechanisms involved in these responses. By elucidating these relationships, the study seeks to enhance treatment strategies for ADHD.
Who should consider this trial
Good fit: Ideal candidates include children aged 6 to 18 years who meet the DSM-5 criteria for ADHD and have a CGI-ADHD-S score greater than 4.
Not a fit: Patients with major psychiatric disorders, significant central nervous system disorders, or those who have previously received ADHD treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized treatment approaches for children with ADHD, improving their response to methylphenidate.
How similar studies have performed: While the efficacy of methylphenidate is well-established, this study's focus on identifying electrophysiological and metabolic biomarkers is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
1. Patients with ADHD
1. Inclusion Criteria
* Patients, aged 6 to 18 years, meet the DSM-5 diagnostic criteria for ADHD.
* At baseline, patients have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score greater than 4.
* Patients have a Full IQ (FIQ) score greater than 80.
2. Exclusion Criteria
* Patients have a major psychiatric disorder, such as autism spectrum disorder, schizophrenia, affective disorders, or substance use disorders.
* Patients have a major disorder of central nervous system, such as epilepsy.
* Patients have a major systemic disease, such as diabetes mellitus or cardiovascular diseases.
* Patients have ever received any medication to treat the clinical symptoms of ADHD.
2. Neurotypical participants:
1. Inclusion Criteria
* aged 6 to 18 years
* All of the neurotypical participants have no psychiatric disorder in lifetime according to the diagnostic criteria of DSM-5.
2. Exclusion Criteria
* participants have any disorder of central nervous system or major systemic disease
* participants have ever taken any psychotropic drug, or who have FIQ scores less than 80, will be excluded from the present study.
Where this trial is running
Taipei
- National Taiwan University Hospital — Taipei, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Chi-Yung Shang, MD, PhD
- Email: cyshang@ntu.edu.tw
- Phone: +886-2-23123456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Methylphenidate, Metabolomics