Attention Deficit Disorder With Hyperactivity (ADHD)NCT07041333
The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD), run by Enes Faruk ALTUNKILIÇ at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 11 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity (ADHD)
- How many people
- 57 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Jul 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 11 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Previous use of psychiatric medication.
- Presence of chronic illness
- Regular use of medication
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospita
Istanbul, Bakırkoy, 34147
About this study
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.
Read the 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.
- Keywords
- methylphenidate, Attention Deficit Hyperactivity Disorder, ADHD, neuroinflammation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neuroinflammatory Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient group | Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Immediately before starting the treatment and up to the 3rd month of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2025
- Study start14 Jul 2025
- Primary completion19 Oct 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With Hyperactivity (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Enes Faruk ALTUNKILIÇ
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Enes Faruk ALTUNKILIÇ, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07041333
- Sponsor's protocol ID
- 2025-04-11
- Other IDs
- Ethics Committee
- Status last verified
- Jan 2026
- First submitted
- 19 Jun 2025
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The participants' age, scores of the clinical scales examined in the study, and levels of serum samples will be shared. In other words, the necessary data relevant to the purpose of the study will be shared.
Publications
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.
PubMed 33114154Leung 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.
PubMed 27426904Kul 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.
PubMed 26207130Koc 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.
PubMed 36879528
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder
- ClinicalTrials.gov ID
- NCT07041333
- Acronym / sponsor ID
- 2025-04-11
- Keywords
- methylphenidate, Attention Deficit Hyperactivity Disorder, ADHD, neuroinflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Enes Faruk ALTUNKILIÇUniversity, hospital or other
- Study start
- 14 Jul 2025 (actual)
- Primary completion
- 19 Oct 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 27 Jun 2025 (actual)
- Results
- Posted 12 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | –Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
Who may qualify
- Ages
- 6 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in IL-6 Marker Level
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
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.
Change in S100B Marker Level
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
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.
Change in the Level of Claudin-5 Marker
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 33114154Corona JC. Role of Oxidative Stress and Neuroinflammation in Attention-Deficit/Hyperactivity Disorder. Antioxidants (Basel). 2020 Oct 23;9(11):1039. doi: 10.3390/antiox9111039.
- Background: PubMed 27426904Leung 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.
- Background: PubMed 26207130Kul 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.
- Background: PubMed 36879528Koc 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.
- Individual participant dataSharing planned: Yes. The participants' age, scores of the clinical scales examined in the study, and levels of serum samples will be shared. In other words, the necessary data relevant to the purpose of the study will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder With Hyperactivity (ADHD), run by Enes Faruk ALTUNKILIÇ at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IL-6 Marker Level (time frame: Immediately before starting the treatment and up to the 3rd month of treatment.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07041333, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.