About this trial
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
This trial accepts healthy volunteersQualifiers
Patients with ADHD
* 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.
Disqualifiers
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.
Trial population
80drug-naïve patients with ADHD, aged 6-18, and 80 age- and sex-matched typically developing controls will be recruited in this project
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
methylphenidate
DrugThe patients with ADHD will receive 12-week treatment with methylphenidate.
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic interview
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
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
Questionnaire
Cases and parents assisted in filling out the Achenbach child behavior check list (CBCL).Each question in this questionnaire is scaled from 1 to 3. The higher the total score, the more severe the emotional and behavioral distress.
Questionnaire
Cases and parents assisted in filling out the Swanson, Nolan, and Pelham Rating Scale Fourth Edition (SNAP-IV).Each question in this questionnaire is scaled from 0 to 3. The higher the total score, the more severe the symptoms.
Questionnaire
Cases and parents assisted in filling out the Family APGAR questionnaire.Each question in this questionnaire is scaled from 0 to 2. The higher the total score, the better the family function.
Questionnaire
Cases and parents assisted in filling out the Social Adjustment Inventory for Children and Adolescents questionnaire (SAICA).The scale for each question in this questionnaire ranges from 1 to 4. The higher the total score, the worse the social adaptation status.
Sponsors and contacts
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