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

NCT ID: NCT07041333

Last Updated: 2026-01-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 57 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-07-14
• Study Completion Date: 2025-12-31

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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patient group

Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 11 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Enes Faruk ALTUNKILIÇ

OTHER

Sponsor Role: lead

Responsible Party

Enes Faruk ALTUNKILIÇ

Child and adolescent psychiatrist

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospita

Istanbul, Bakırkoy, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Hogasen AK, Hestdal K, Abrahamsen TG. Granulocyte-macrophage colony-stimulating factor, but not macrophage colony-stimulating factor, suppresses basal and lipopolysaccharide-stimulated complement factor production in human monocytes. J Immunol. 1993 Sep 15;151(6):3215-24.

Reference Type: RESULT

PMID: 7690797 (View on PubMed)

Leung AK, Hon KL. Attention-Deficit/Hyperactivity Disorder. Adv Pediatr. 2016 Aug;63(1):255-80. doi: 10.1016/j.yapd.2016.04.017. No abstract available.

Reference Type: RESULT

PMID: 27426904 (View on PubMed)

Kul M, Unal F, Kandemir H, Sarkarati B, Kilinc K, Kandemir SB. Evaluation of Oxidative Metabolism in Child and Adolescent Patients with Attention Deficit Hyperactivity Disorder. Psychiatry Investig. 2015 Jul;12(3):361-6. doi: 10.4306/pi.2015.12.3.361. Epub 2015 Jul 6.

Reference Type: RESULT

PMID: 26207130 (View on PubMed)

Koc S, Guler EM, Derin S, Gultekin F, Aktas S. Oxidative and Inflammatory Parameters in Children and Adolescents With ADHD. J Atten Disord. 2023 Jun;27(8):880-886. doi: 10.1177/10870547231159907. Epub 2023 Mar 6.

Reference Type: RESULT

PMID: 36879528 (View on PubMed)

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

Etik komite

Identifier Type: OTHER

Identifier Source: secondary_id

2025-04-11

Identifier Type: -

Identifier Source: org_study_id