Exploration of the Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With Attention-Deficit/Hyperactivity Disorder
Overview
- Phase
- Not Applicable
- Intervention
- methylphenidate
- Conditions
- Methylphenidate
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 160
- Locations
- 1
- Primary Endpoint
- Diagnostic interview
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
ADHD GROUP
Subjects with clinical diagnosis of ADHD according to the DSM-V criteria
Intervention: methylphenidate
Outcomes
Primary Outcomes
Diagnostic interview
Time Frame: 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
Time Frame: 15 minutes
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.
Secondary Outcomes
- liquid chromatography-mass spectrometry and gas chromatography-mass spectrometry(5 minutes)
- Neuropsychological testing(1.5 hours)
- Questionnaire(5minutes)
- Neurobiological assessments(20minutes)