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

NCT07041333 | Completed Results

• 2 other identifiers: 2025-04-11Ethics Committee
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Attention Deficit Disorder With Hyperactivity (ADHD)

Keywords

methylphenidate; Attention Deficit Hyperactivity Disorder; ADHD; neuroinflammation

Outcome Measures

Primary Outcomes (3)

• Change in IL-6 Marker Level

  Interleukin-6 (IL-6) level was measured according to the human ELISA kit protocol. Serum samples from 42 patients were compared immediately before and after 3 months of treatment. IL-6 was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E0090Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-IL-6 antibody. Incubated at 37°C for 60 minutes. plate was washed 5 times with wash buffer. 50μl of substrate solution A was added to the wells and then 50μl of substrate solution B was added to each well. The plate was incubated for 10 minutes at 37°C in the dark. 50μl of Stop Solution was added to the wells and the blue color immediately changed to yellow. The optical density (OD value) of each well was determined using a microplate reader set to 450 nm within 10 min after adding the stop solution.

  Immediately before starting the treatment and up to the 3rd month of treatment.

• Change in S100B Marker Level

  S100 Calcium Binding Protein B (S100B) level was measured according to the human ELISA kit protocol. Serum samples from 42 patients were compared immediately before and after 3 months of treatment. S100B was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E3887Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-S100B antibody. Incubated at 37°C for 60 minutes. plate was washed 5 times with wash buffer. 50μl of substrate solution A was added to the wells and then 50μl of substrate solution B was added to each well. The plate was incubated for 10 minutes at 37°C in the dark. 50μl of Stop Solution was added to the wells and the blue color immediately changed to yellow. The optical density (OD value) of each well was determined using a microplate reader set to 450 nm within 10 min after adding the stop solution.

  Immediately before starting the treatment and up to the 3rd month of treatment.

• Change in the Level of Claudin-5 Marker

  Claudin 5 level was measured according to the human ELISA kit protocol. Serum samples from 42 patients were compared immediately before and after 3 months of treatment. Claudin 5 was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E2303Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-Claudin 5 antibody. Incubated at 37°C for 60 minutes. plate was washed 5 times with wash buffer. 50μl of substrate solution A was added to the wells and then 50μl of substrate solution B was added to each well. The plate was incubated for 10 minutes at 37°C in the dark. 50μl of Stop Solution was added to the wells and the blue color immediately changed to yellow. The optical density (OD value) of each well was determined using a microplate reader set to 450 nm within 10 min after adding the stop solution.

  Immediately before starting the treatment and up to the 3rd month of treatment.

Study Arms (1)

Patient group

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

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Patients who applied to Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital, diagnosed with Attention Deficit Hyperactivity Disorder, deemed suitable for methylphenidate treatment, and for whom methylphenidate treatment is planned, have been referred to us.

You may qualify if:

• 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.
• The participant must be between 6 and 11 years of age.
• The participant must agree to participate in the study after being informed about it.

You may not qualify if:

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

Sponsors & Collaborators

• Enes Faruk ALTUNKILIÇ: lead

Study Sites (1)

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

Istanbul, Bakırkoy, 34147, Turkey (Türkiye)

Location

Related Publications (4)

• Corona JC. Role of Oxidative Stress and Neuroinflammation in Attention-Deficit/Hyperactivity Disorder. Antioxidants (Basel). 2020 Oct 23;9(11):1039. doi: 10.3390/antiox9111039.

  PMID: 33114154 BACKGROUND

• 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.

  PMID: 27426904 BACKGROUND

• 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.

  PMID: 26207130 BACKGROUND

• 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.

  PMID: 36879528 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neuroinflammatory Diseases

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Nervous System Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Enes Faruk ALTUNKILIÇ
• Organization: Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital

enesfarukaltunkilic@gmail.com

+90 (507) 736 21 91

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Child and adolescent psychiatrist

Study Record Dates

• First Submitted: June 19, 2025
• First Posted: June 27, 2025
• Study Start: July 14, 2025
• Primary Completion: October 19, 2025
• Study Completion: December 31, 2025
• Last Updated: February 24, 2026
• Results First Posted: February 12, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF

Locations

TU (1)