The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder

Recruiting

• Conditions: Attention Deficit Disorder With Hyperactivity (ADHD)

• Registration Number: NCT07041333
• Lead Sponsor: Enes Faruk ALTUNKILIÇ

Brief Summary

The aim of this study was to investigate the effect of treatment of ADHD with methylphenidate on neuroinflammation by examining the levels of Interleukin-6 (IL-6), S100B, Claudin-5 in serum samples of patients who were diagnosed with attention deficit hyperactivity disorder (ADHD) and started or planned to start methylphenidate for treatment as per routine, at month 0 before the initiation of methylphenidate treatment and at month 3 after the initiation of treatment.

Detailed Description

After informed consent, a structured clinical interview for DSM-5-TR will be conducted using the "Emotional Disorders and Schizophrenia Form for School-Age Children - Current and Lifetime Form DSM-5 - Turkish Adaptation (ÇDŞG-ŞY-DSM-5-T)". The "Sociodemographic and Clinical Data Form" created by the researchers will be completed to obtain sociodemographic and clinical data for the participants. The "Conners Parent Rating Scale-Revised Short Form" and "Conners Teacher Rating Scale-Revised Short Form" will be administered to the group diagnosed with ADHD to determine the severity of the disease, symptoms, and predominant subtypes. After the diagnosis is made and evaluated according to the exclusion criteria, peripheral venous blood will be collected in yellow-capped tubes between 9 and 12 a.m. after a 10-12 hour fast, prior to the routine planned methylphenidate treatment. After being left at room temperature for 10-20 minutes, the blood will be centrifuged at 3000 RPM for 20 minutes, and the serum portion will be collected into Eppendorf tubes and stored at -80 degrees until the samples are analyzed. Three months after starting treatment, blood will be collected and stored in the same manner. After all samples have been collected, the serum samples will be analyzed in a single batch for Interleukin-6 (IL-6), S100B, and Claudin-5 levels using human ELISA kit protocols at the Medical Biochemistry Laboratory of Bakırköy Dr. Sadi Konuk Training and Research Hospital by biochemistry specialist Dr. Hacer Eroğlu İçli. Three months after the start of treatment, the Conners Parent Rating Scale - Revised Short Form and the Conners Teacher Rating Scale - Revised Short Form will be administered again.

Study Timeline

• Study First Submitted: 2025-06-19
• Study First Submitted QC: 2025-06-19
• Study First Posted: 2025-06-27
• Status Verified: 2025-07
• Study Start: 2025-07-14
• Last Update Submitted: 2025-07-24
• Last Update Posted: 2025-07-25
• Primary Completion: 2025-09-19
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

1. According to DSM-5 TR, the participant must have a diagnosis of "Attention Deficit Hyperactivity Disorder" and have started/be planning to start routine methylphenidate treatment.
2. The participant must be between 6 and 11 years of age.
3. The participant must agree to participate in the study after being informed about it.

Exclusion Criteria

1. The presence of a psychiatric disorder diagnosis other than Attention Deficit Hyperactivity Disorder
2. Having a diagnosis of Attention Deficit Hyperactivity Disorder but not planning to start methylphenidate
3. Being under 6 years of age or over 11 years of age
4. Having organic brain damage, mental retardation, autism spectrum disorder, neurological disease, or a physical illness that affects neurocognitive functions
5. History of alcohol and/or psychoactive substance use
6. Presence of ongoing active infection, allergic disease, and chronic illness
7. Previous use of psychiatric medication.
8. Presence of chronic illness
9. Regular use of medication

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in IL-6 marker level	Immediately before starting the treatment and up to the 3rd month of treatment.
Change in S100B marker level	Immediately before starting the treatment and up to the 3rd month of treatment.
Change in the level of claudin-5 marker	Immediately before starting the treatment and up to the 3rd month of treatment.

Trial Locations

Locations (1)

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