The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)

• Registration Number: NCT06844812
• Lead Sponsor: Saglik Bilimleri Universitesi

Brief Summary

The aim of this study is to investigate the effect of methylphenidate treatment on oxidative stress by measuring the levels of Total Oxidant Status (TOS), Total Antioxidant Status (TAS), Oxidative Stress Index (OSI=TOS/TAS), Malondialdehyde (MDA), Oxidized LDL (Ox-LDL), and Superoxide Dismutase (SOD) in serum samples of patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who have either started or are planned to start methylphenidate treatment. The measurements will be taken at baseline (0 months, before treatment initiation) and at the 3rd month (after treatment has begun) to assess the effect of methylphenidate on oxidative stress. Patients who were already planned to begin methylphenidate treatment will be invited to participate in this study. Since this is not an interventional study, no additional treatments will be administered or altered beyond the treatment the patient is already required to receive.

Detailed Description

The study population will consist of patients who are diagnosed with "Attention Deficit Hyperactivity Disorder (ADHD)" according to DSM-5-TR, who have applied to the child and adolescent psychiatry outpatient clinics of Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital and have been started or planned to start methylphenidate treatment by the physician they have been examined by. After an in-clinic announcement, these patients will be directed to the researcher, Enes Faruk Altunkılıç. After being informed both verbally and in writing through the informed consent process, those who agree to participate, sign the informed consent form, and meet the inclusion and exclusion criteria will be included in the study. It will also be explained to the patients and their families that their participation or non-participation in this study will not affect the treatment they will receive.

After informed consent, a structured clinical interview for DSM-5-TR will be conducted using the "Mood Disorders and Schizophrenia Form for School-Aged Children - Now and Lifetime DSM-5 - Turkish Adaptation (ÇDŞG-ŞY-DSM-5-T)." To obtain sociodemographic and clinical data for the participants, the "Sociodemographic and Clinical Data Form" created by the researchers will be completed. For the ADHD diagnosed group, the "Conners Parent Rating Scale - Revised Short" and "Conners Teacher Rating Scale - Revised Short" will be applied to determine the severity of the disorder, symptoms, and predominant subtyping. After the diagnosis is made and evaluated according to the exclusion criteria, blood samples will be taken from the patient after a 10-12 hour fasting period, between 9-12 AM, in a yellow-capped tube, before the routine methylphenidate treatment is used. After waiting for 10-20 minutes at room temperature, the sample will be centrifuged at 3000 RPM for 20 minutes, and the serum will be collected in Eppendorf tubes and stored at -80°C until analysis. After 3 months of treatment, blood samples will be taken again in the same manner and stored. Once all the samples are collected, the serum samples will be analyzed for total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), superoxide dismutase (SOD), and oxidized LDL levels according to the human ELISA kit protocols at the Biochemistry Laboratory of Bakırköy Dr. Sadi Konuk Training and Research Hospital by biochemist Dr. Hacer Eroğlu İçli. After 3 months of treatment, the Conners Parent Rating Scale - Revised Short and Conners Teacher Rating Scale - Revised Short forms will be applied again. In addition to the markers, the Oxidative Stress Index (OSI = TOS/TAS) will be calculated and included in the evaluation before and 3 months after the treatment.

Study Timeline

• Study Start: 2024-06-26
• Primary Completion: 2025-01-06
• Study Completion: 2025-01-06
• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-19
• Last Update Submitted: 2025-02-19
• Study First Posted: 2025-02-25
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• • A diagnosis of "Attention Deficit Hyperactivity Disorder" according to DSM-5 TR, and the initiation or planned initiation of methylphenidate treatment as part of routine care.
• Being between the ages of 6 and 11.
• Providing consent to participate in the study after being informed about the study.

Exclusion Criteria

• • Presence of a psychiatric disorder diagnosis other than "Attention Deficit Hyperactivity Disorder."
• The diagnosis of "Attention Deficit Hyperactivity Disorder" has been made, but methylphenidate treatment has not been planned.
• Being under the age of 6 or over the age of 11.
• Presence of organic brain damage, mental retardation, autism spectrum disorder, neurological diseases, or any physical illness affecting neurocognitive functions.
• A history of alcohol and/or psychoactive substance use.
• Presence of ongoing active infection, allergic diseases, or chronic illness.
• Previous use of psychiatric medication.
• Presence of a chronic illness.
• Use of regular medication.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The change in oxidative stress markers after 3 months of treatment.	Immediately before starting the treatment and up to the 3rd month of treatment.	Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Malondialdehyde (MDA), Superoxide Dismutase (SOD), and Oxidized LDL levels were measured according to human ELISA kit protocols. Serum samples taken from 39 patients immediately before starting treatment and after 3 months of treatment were compared.
The change in the "Conners Parent and Teacher Revised Short" scales after 3 months of treatment and its relationship with the change in serum levels.	Before starting the treatment and up to the 3rd month of treatment.	Immediately before starting the treatment, the "Conners Parent and Teacher Revised Short" scales were completed by the teachers and families. These scales were repeated at the 3rd month of treatment. The relationship between the changes in these scales and the changes in serum levels was examined.; In the scale, 0 represents "never/rarely," while 4 represents "very often."

Trial Locations

Locations (1)

Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital; 🇹🇷 Istanbul, Bakirkoy, Turkey