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| ID | Type | Description | Link |
|---|---|---|---|
| Ethics Committee | Other Identifier | akırköy Ptof. Dr. Sadi Konuk Training and Research Hospital Clinical Research Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient group | Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospita | Istanbul | Bakırkoy | 34147 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33114154 | Background | 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. | |
| 27426904 | 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. |
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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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Initially, 42 patients were enrolled in the study. During the follow-up period, a new patient was recruited to replace each patient who withdrew before completing the study. Consequently, a total of 57 patients were enrolled, and 15 patients withdrew from the study for various reasons.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Group | Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Group | Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | ng/L | Immediately before starting the treatment and up to the 3rd month of treatment. |
|
3 months
Patients diagnosed with attention deficit hyperactivity and planned to receive methylphenidate treatment were included in the study. Patients eligible for methylphenidate treatment due to indication were included. Therefore, there were no patients at risk of death or serious adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Group | Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| loss of appetite | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in 7 children, whereas it persisted throughout the 3-month period in the other 15 children. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Enes Faruk ALTUNKILIÇ | Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital | +90 (507) 736 21 91 | enesfarukaltunkilic@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Jun 19, 2025 | Jan 26, 2026 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D000090862 | Neuroinflammatory Diseases |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009422 | Nervous System Diseases |
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serum
| Immediately before starting the treatment and up to the 3rd month of treatment. |
| 26207130 | 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. |
| 36879528 | 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. |
| Medication refusal by the family. |
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| The family's request to obtain a second medical opinion. |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| kilogram (kg) | Mean | Standard Deviation | kilogram (kg) |
|
| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m² |
|
| Body Mass Index (BMI) z-score | BMI-for-age Z-score (age- and sex-standardized). Z=0 is the reference mean; +1 and +2 indicate 1 and 2 SD above the mean, respectively; negative values indicate below-average BMI. Higher Z-scores indicate higher BMI. Clinically relevant cut points: Z ≥ +2 obesity; Z ≥ +1 overweight; Z ≤ -2 underweight/thinness; Z ≤ -3 severe thinness. | Mean | Standard Deviation | z-score |
|
| Height | Mean | Standard Deviation | Centimeters (cm) |
|
| School year (year(s)) | Median | Inter-Quartile Range | years |
|
| ADHD presentation type | Count of Participants | Participants |
|
| Patient Group |
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study |
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ng/L | Immediately before starting the treatment and up to the 3rd month of treatment. |
|
|
|
|
| Primary | 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. | Posted | Median | Inter-Quartile Range | ng/L | Immediately before starting the treatment and up to the 3rd month of treatment. |
|
|
|
|
| 0 |
| 57 |
| 0 |
| 57 |
| 30 |
| 57 |
|
| Weight loss | General disorders | Non-systematic Assessment | This adverse effect was observed throughout the 3-month period in one child. |
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| Headache | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in three children. |
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| Dizziness | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in one child. |
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| abdominal pain | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in four children. |
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| Nausea | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in four children. |
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| Agitation | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in one child. |
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| Extreme stagnation | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in seven children. |
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| Chest pain | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in one child. |
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| Tachycardia | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in one child. |
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| Difficulty falling asleep at night | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in three children, whereas it persisted throughout the 3-month period in one child. |
|
| Blurred vision | General disorders | Non-systematic Assessment | This adverse effect was observed transiently within the first 3 months in one child. |
|
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| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |