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

NCT06073470 | Recruiting FDA Drug

• 1 other identifier: 202204054RINC
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

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.

Conditions

Methylphenidate; Metabolomics

Outcome Measures

Primary Outcomes (2)

• 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).

  1 hour

• 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.

  15 minutes

Secondary Outcomes (12)

• Questionnaire

  5minutes

• Questionnaire

  5minutes

• Questionnaire

  5minutes

• Questionnaire

  5minutes

• Questionnaire

  5minutes

Study Arms (2)

ADHD GROUP

Subjects with clinical diagnosis of ADHD according to the DSM-V criteria

Drug: methylphenidate

TD GROUP

Typically development controls without lifetime diagnosis with ADHD

Interventions

methylphenidate DRUG

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

ADHD GROUP

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Neurotypical participants:
• aged 6 to 18 years
• All of the neurotypical participants have no psychiatric disorder in lifetime according to the diagnostic criteria of DSM-5.
• 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.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma

MeSH Terms

Interventions

Methylphenidate

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Susan Shur-Fen Gau, MD, PhD

  Department of Psychiatry, National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Chi-Yung Shang, MD, PhD

CONTACT

+886-2-23123456; cyshang@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: October 10, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 26, 2024

Record last verified: 2023-09

Locations

TW (1)