Clinical trial NCT06073470: Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD
Official title: Exploration of the Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With Attention-Deficit/Hyperactivity Disorder
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Methylphenidate
Metabolomics
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-10-10
Enrollment: 160
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 80drug-naïve patients with ADHD, aged 6-18, and 80 age- and sex-matched typically developing controls will be recruited in this project

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.

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:

1. To examine the differences in electrophysiology and metabolomics between children with ADHD and neurotypical controls.
2. 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.
3. 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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic interview
timeFrame: 1 hour
measure: ADHD symptoms
timeFrame: 15 minutes
Secondary outcomes:
measure: Questionnaire
timeFrame: 5minutes
measure: Questionnaire
timeFrame: 5minutes
measure: Questionnaire
timeFrame: 5minutes
measure: Questionnaire
timeFrame: 5minutes
measure: Questionnaire
timeFrame: 5minutes
measure: Neurobiological assessments
timeFrame: 10minutes
measure: Neurobiological assessments
timeFrame: 10minutes
measure: Neurobiological assessments
timeFrame: 10minutes
measure: Neurobiological assessments
timeFrame: 30minutes
measure: Neurobiological assessments
timeFrame: 20minutes
measure: liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry
timeFrame: 5 minutes
measure: Neuropsychological testing
timeFrame: 1.5 hours
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: Department of Psychiatry, National Taiwan University Hospital
name: Susan Shur-Fen Gau, MD, PhD
role: STUDY_DIRECTOR
References: