Metabolic Mechanisms of the Electrophysiological Biomarkers for Response to Methylphenidate Treatment in Children With ADHD

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-18
SponsorNational Taiwan University Hospital

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • methylphenidate

    Drug

    The patients with ADHD will receive 12-week treatment with methylphenidate.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: ADHD GROUP1 intervention
Group B: TD GROUP0 interventions

Trial outcomes

Primary outcomes

1

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).

Time frame
1 hour
2

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.

Time frame
15 minutes

Secondary outcomes

1

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.

Time frame
5minutes
2

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.

Time frame
5minutes
3

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.

Time frame
5minutes
4

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.

Time frame
5minutes

Other outcomes

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