The Neuroprotective Effects of Methylphenidate and Atomoxetine in Children With ADHD: A Lipidomic Study

NCT03936491 | Completed DMC

• 1 other identifier: 201812200MINA
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To identify the difference in the lipidomic profiles between ADHD and controls;
2. 2.To examine the effects of methylphenidate and atomoxetine on the lipidomic profiles in ADHD, and the relationship between medication-related changes in the lipidomic profiles and medication-related improvements in the behavioral symptoms and neuropsychological functions;
3. 3.To map medication-related lipidomic biomolecules to their respective metabolic pathways to identify the underlying mechanisms of neuroprotective effects of methylphenidate and atomoxetine.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

biomarker; ADHD

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale-IV-Parent version: Investigator-Administered and Scored (ADHDRS-IV)

  The first efficacy measure is the ADHDRS-IV, which is a scale composed of 18 items. The investigator will conduct a semi-structured interview with the parent to evaluate the severity of ADHD symptoms in the past week. ADHDRS-IV is a valid and reliable tool to assess the severity of ADHD symptoms, which has been widely used in pharmacological studies of ADHD in Taiwanese populations. ADHDRS-IV will be administered from visit 1 through visit 5 (baseline-week 12).

  12 weeks

Secondary Outcomes (1)

• Swanson, Nolan, and Pelham IV scale (SNAP-IV), Parent Form and Teacher Form

  12 weeks

Study Arms (2)

Methylphenidate

EXPERIMENTAL

The subjects will receive methylphenidate according to their clinical symptoms

Drug: Methylphenidate

Atomoxetine

ACTIVE COMPARATOR

The subjects will receive atomoxetine according to their clinical symptoms

Drug: Atomoxetine

Interventions

Methylphenidate DRUG

Methylphenidate is a central nervous system stimulant used for the therapy of attention deficit disorder and narcolepsy.

Also known as: Ritalin

Methylphenidate

Atomoxetine DRUG

Atomoxetine is a medication used to treat attention deficit hyperactivity disorder (ADHD).\[6\] Use is only recommended in those who are at least six years old.\[6\] It is taken by mouth.\[6\]

Also known as: Strattera

Atomoxetine

Eligibility Criteria

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

You may qualify if:

• Children or adolescents, between 6 and 18 years of age, must have ADHD based on the diagnostic criteria of the Diagnostic and Statistical Manual of Mental disorders, 5th edition.
• Their scores of Clinical Global Impressions-ADHD-Severity (CGI-ADHD-S) is greater than 4 at baseline.
• They have to be medication-naïve. They never receive any medication for the treatment of ADHD.
• They and their parents must understand sufficiently to communicate properly with the investigators.
• They must have a Full-Scale Intelligence Quotient (FIQ) score greater than 80.
• They must keep regular clinic visits and all required tests, including collection of blood sample and neuropsychological testing.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; Atomoxetine Hydrochloride

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

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

Study Officials

• Chi-Yung Shang Shang, MDPHD

  Dept of Psychiatry, National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2019
• First Posted: May 3, 2019
• Study Start: August 1, 2019
• Primary Completion: January 25, 2021
• Study Completion: January 25, 2021
• Last Updated: April 16, 2024

Record last verified: 2024-04

Locations

TW (1)