Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD
Study Details
Study Description
Brief Summary
To explore the relationship of treatment-related changes in electrophysiology and those in metabolomics for identification of the underlying metabolic mechanisms for the electrophysiological effects of methylphenidate in children with ADHD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Detailed Description
Although the efficacy of methylphenidate in reducing the core symptoms of attentiondeficit/ hyperactivity disorder (ADHD) is well documented in clinical trials, no definite biomarker has been identified to differentiate responders from non-responders to methylphenidate treatment for children with ADHD. In addition, the neural and metabolic mechanisms underlying the therapeutic effects of methylphenidate remain to be elucidated. In this 4-year prospective project, the investigators will explore the effects of 12-week treatment with methylphenidate on the electrophysiology and metabolomics of children with ADHD to identify the biomarkers for predicting the clinical response to methylphenidate. In addition, the investigators will explore the metabolic mechanisms through which methylphenidate treatment may modulate the abnormality in the electrophysiology of children with ADHD.
Specific Aims:
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To examine the differences in electrophysiology and metabolomics between children with ADHD and neurotypical controls.
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To examine the differences in the change of electrophysiology and metabolomics after 12-week treatment with methylphenidate between responders and non-responders in children with ADHD.
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To explore the relationship of treatment-related changes in electrophysiology and those in metabolomics for identification of the underlying metabolic mechanisms for the electrophysiological effects of methylphenidate in children with ADHD.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| ADHD GROUP Subjects with clinical diagnosis of ADHD according to the DSM-V criteria |
Drug: methylphenidate
The patients with ADHD will receive 12-week treatment with methylphenidate.
|
| TD GROUP Typically development controls without lifetime diagnosis with ADHD |
Outcome Measures
Primary Outcome Measures
- Diagnostic interview [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 [15 minutes]
Subjects will be interviewed by ADHDRS-IV , which consists of 18 items to measure the symptomatology of ADHD .
Secondary Outcome Measures
- Questionnaire [5minutes]
Cases and parents assisted in filling out the CBCL questionnaire
- Questionnaire [5minutes]
Cases and parents assisted in filling out the SNAP-IV questionnaire
- Questionnaire [5minutes]
Cases and parents assisted in filling out the Family APGAR questionnaire
- Questionnaire [5minutes]
Cases and parents assisted in filling out the Family SAICA questionnaire
- Questionnaire [5minutes]
Cases and parents assisted in filling out the Family BRIEFquestionnaire
- Neurobiological assessments [10minutes]
Resting state EEG will be recorded in NTUH ERP lab
- Neurobiological assessments [30minutes]
auditory MMN/P3a (task-free ERP) will be recorded in NTUH ERP .
- Neurobiological assessments [20minutes]
dichotic continuous performance task(DCPT, task-related ERP modified from Conner's CATA) will be recorded in NTUH ERP lab.
- liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry [5 minutes]
Whole blood samples will be collected after 8 hours of fasting at baseline and week 12 for neurotypical controls and for patients with ADHD. The investigators will employ both liquid chromatography coupled to mass spectrometry (LC/MS) and gas chromatography coupled to mass spectrometry (GC/MS) to conduct the experiments of metabolomic profiling of the serum at the Metabolomics Core Laboratory, National Taiwan University.
- Neuropsychological testing [1.5 hours]
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.
Eligibility Criteria
Criteria
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Patients with ADHD
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Inclusion Criteria
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Patients, aged 6 to 18 years, meet the DSM-5 diagnostic criteria for ADHD.
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At baseline, patients have a Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) score greater than 4.
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Patients have a Full IQ (FIQ) score greater than 80.
- Exclusion Criteria
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Patients have a major psychiatric disorder, such as autism spectrum disorder, schizophrenia, affective disorders, or substance use disorders.
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Patients have a major disorder of central nervous system, such as epilepsy.
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Patients have a major systemic disease, such as diabetes mellitus or cardiovascular diseases.
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Patients have ever received any medication to treat the clinical symptoms of ADHD.
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Neurotypical participants:
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Inclusion Criteria
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aged 6 to 18 years
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All of the neurotypical participants have no psychiatric disorder in lifetime according to the diagnostic criteria of DSM-5.
- Exclusion Criteria
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participants have any disorder of central nervous system or major systemic disease
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participants have ever taken any psychotropic drug, or who have FIQ scores less than 80, will be excluded from the present study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Study Director: Susan Shur-Fen Gau, MD, PhD, Department of Psychiatry, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 202204054RINC