Attention Deficit Hyperactivity Disorder (ADHD)NCT06844812
The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
An observational study of Attention Deficit Hyperactivity Disorder (ADHD), run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to investigate the effect of methylphenidate treatment on oxidative stress by measuring the levels of Total Oxidant Status (TOS), Total Antioxidant Status (TAS), Oxidative Stress Index (OSI=TOS/TAS), Malondialdehyde (MDA), Oxidized LDL (Ox-LDL), and Superoxide Dismutase (SOD) in serum samples… Read more about this study
- Who is it for?
- Ages 6 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Jun 2024to 6 Jan 2025
- How long will I take part?
- 3 Months
- 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
- Healthy volunteers accepted
- 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
- - A diagnosis of "Attention Deficit Hyperactivity Disorder" according to DSM-5 TR, and the initiation or planned initiation of methylphenidate treatment as part of routine care.
- Being between the ages of 6 and 11.
- Providing consent to participate in the study after being informed about the study.
Who cannot join
- - Presence of a psychiatric disorder diagnosis other than "Attention Deficit Hyperactivity Disorder."
- The diagnosis of "Attention Deficit Hyperactivity Disorder" has been made, but methylphenidate treatment has not been planned.
- Being under the age of 6 or over the age of 11.
- Presence of organic brain damage, mental retardation, autism spectrum disorder, neurological diseases, or any physical illness affecting neurocognitive functions.
- A history of alcohol and/or psychoactive substance use.
- Presence of ongoing active infection, allergic diseases, or chronic illness.
Show all 9Show fewer
- Previous use of psychiatric medication.
- Presence of a chronic illness.
- Use of regular 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 Hospital
Istanbul, Bakirkoy, 34147
About this study
The aim of this study is to investigate the effect of methylphenidate treatment on oxidative stress by measuring the levels of Total Oxidant Status (TOS), Total Antioxidant Status (TAS), Oxidative Stress Index (OSI=TOS/TAS), Malondialdehyde (MDA), Oxidized LDL (Ox-LDL), and Superoxide Dismutase (SOD) in serum samples of patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who have either started or are planned to start methylphenidate treatment. The measurements will be taken at baseline (0 months, before treatment initiation) and at the 3rd month (after treatment has begun) to assess the effect of methylphenidate on oxidative stress. Patients who were already planned to begin methylphenidate treatment will be invited to participate in this study. Since this is not an interventional study, no additional treatments will be administered or altered beyond the treatment the patient is already required to receive.
Read the detailed description
The study population will consist of patients who are diagnosed with "Attention Deficit Hyperactivity Disorder (ADHD)" according to DSM-5-TR, who have applied to the child and adolescent psychiatry outpatient clinics of Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital and have been started or planned to start methylphenidate treatment by the physician they have been examined by. After an in-clinic announcement, these patients will be directed to the researcher, Enes Faruk Altunkılıç. After being informed both verbally and in writing through the informed consent process, those who agree to participate, sign the informed consent form, and meet the inclusion and exclusion criteria will be included in the study. It will also be explained to the patients and their families that their participation or non-participation in this study will not affect the treatment they will receive.
After informed consent, a structured clinical interview for DSM-5-TR will be conducted using the "Mood Disorders and Schizophrenia Form for School-Aged Children - Now and Lifetime DSM-5 - Turkish Adaptation (ÇDŞG-ŞY-DSM-5-T)." To obtain sociodemographic and clinical data for the participants, the "Sociodemographic and Clinical Data Form" created by the researchers will be completed. For the ADHD diagnosed group, the "Conners Parent Rating Scale - Revised Short" and "Conners Teacher Rating Scale - Revised Short" will be applied to determine the severity of the disorder, symptoms, and predominant subtyping. After the diagnosis is made and evaluated according to the exclusion criteria, blood samples will be taken from the patient after a 10-12 hour fasting period, between 9-12 AM, in a yellow-capped tube, before the routine methylphenidate treatment is used. After waiting for 10-20 minutes at room temperature, the sample will be centrifuged at 3000 RPM for 20 minutes, and the serum will be collected in Eppendorf tubes and stored at -80°C until analysis. After 3 months of treatment, blood samples will be taken again in the same manner and stored. Once all the samples are collected, the serum samples will be analyzed for total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), superoxide dismutase (SOD), and oxidized LDL levels according to the human ELISA kit protocols at the Biochemistry Laboratory of Bakırköy Dr. Sadi Konuk Training and Research Hospital by biochemist Dr. Hacer Eroğlu İçli. After 3 months of treatment, the Conners Parent Rating Scale - Revised Short and Conners Teacher Rating Scale - Revised Short forms will be applied again. In addition to the markers, the Oxidative Stress Index (OSI = TOS/TAS) will be calculated and included in the evaluation before and 3 months after the treatment.
- Being tested
- This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.
- Keywords
- methylphenidate, Attention Deficit Hyperactivity Disorder, ADHD, oxidative stress
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.Other
Also called methylphenidate, ADHD treatment
This is not an interventional study. Patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), for whom methylphenidate treatment is planned, have been invited to participate in the study. The patients have been enrolled in follow-up, and our contact information has been provided to them. As part of routine care, patients have been called in once a month. Necessary dosage adjustments have been made in accordance with medical guidelines, without any intervention for the study. Patients with complaints or those who needed to be seen earlier have been seen in between. As a result, the patients were followed for a total of 3 months for this study. Serum samples for oxidative stress markers were collected at baseline (before treatment started) and at the 3rd month (after treatment began).
| 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 Receives: Other: This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Total Oxidant Status
Total Oxidant Status (TOS) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. TOS was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1599Hu):
Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Total Antioxidant Status
Total antioxidant status (TAS) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment.TAS was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E4350Hu):
Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Superoxide Dismutas
superoxide dismutas level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. Superoxide dismutas was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E0918Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Malondialdehyde
Malondialdehyde (MDA) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. MDA was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1371Hu):
Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Ox-LDL
Ox-LDL level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. Ox-LDL was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1521Hu):
Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Oxidative Stress Index (OSI)
Oxidative Stress Index (OSI) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment.
OSI is an index created by the ratio of TOS to TAS. OSI is a parameter that shows the direction in which the body's oxidative stress balance shifts. An increase or decrease in the OSI value indicates that the oxidative balance has changed. While an increase in OSI value indicates a change in balance in favor of oxidants; a decrease in OSI value indicates a change in balance in favor of anti-oxidants.
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 posted25 Feb 2025
- Study start26 Jun 2024
- Primary completion6 Jan 2025
- Study completion6 Jan 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 (6)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe sponsor's other registered studies.
- 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
- 39 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Enes Faruk ALTUNKILIÇ, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844812
- Sponsor's protocol ID
- 2024-05-27
- Status last verified
- May 2025
- First submitted
- 15 Feb 2025
- Last updated
- 8 Jun 2025
- 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
Smaga I, Niedzielska E, Gawlik M, Moniczewski A, Krzek J, Przegalinski E, Pera J, Filip M. Oxidative stress as an etiological factor and a potential treatment target of psychiatric disorders. Part 2. Depression, anxiety, schizophrenia and autism. Pharmacol Rep. 2015 Jun;67(3):569-80. doi: 10.1016/j.pharep.2014.12.015. Epub 2015 Jan 5.
PubMed 25933971Koc 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 36879528Corona 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 33114154Kul 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 26207130Cunill R, Castells X. [Attention deficit hyperactivity disorder]. Med Clin (Barc). 2015 Apr 20;144(8):370-5. doi: 10.1016/j.medcli.2014.02.025. Epub 2014 Apr 29. Spanish.
PubMed 24787685Leung 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 27426904
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT06844812
- Acronym / sponsor ID
- 2024-05-27
- Keywords
- methylphenidate, Attention Deficit Hyperactivity Disorder, ADHD, oxidative stress
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 6 Jan 2025 (actual)
- Study completion
- 6 Jan 2025 (actual)
- First posted
- 25 Feb 2025 (actual)
- Results
- Posted 8 Jun 2025
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 is to investigate the effect of methylphenidate treatment on oxidative stress by measuring the levels of Total Oxidant Status (TOS), Total Antioxidant Status (TAS), Oxidative Stress Index (OSI=TOS/TAS), Malondialdehyde (MDA), Oxidized LDL (Ox-LDL), and Superoxide Dismutase (SOD) in serum samples of patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) who have either started or are planned to start methylphenidate treatment. The measurements will be taken at baseline (0 months, before treatment initiation) and at the 3rd month (after treatment has begun) to assess the effect of methylphenidate on oxidative stress. Patients who were already planned to begin methylphenidate treatment will be invited to participate in this study. Since this is not an interventional study, no additional treatments will be administered or altered beyond the treatment the patient is already required to receive.
Detailed description
The study population will consist of patients who are diagnosed with "Attention Deficit Hyperactivity Disorder (ADHD)" according to DSM-5-TR, who have applied to the child and adolescent psychiatry outpatient clinics of Bakırköy Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital and have been started or planned to start methylphenidate treatment by the physician they have been examined by. After an in-clinic announcement, these patients will be directed to the researcher, Enes Faruk Altunkılıç. After being informed both verbally and in writing through the informed consent process, those who agree to participate, sign the informed consent form, and meet the inclusion and exclusion criteria will be included in the study. It will also be explained to the patients and their families that their participation or non-participation in this study will not affect the treatment they will receive.
After informed consent, a structured clinical interview for DSM-5-TR will be conducted using the "Mood Disorders and Schizophrenia Form for School-Aged Children - Now and Lifetime DSM-5 - Turkish Adaptation (ÇDŞG-ŞY-DSM-5-T)." To obtain sociodemographic and clinical data for the participants, the "Sociodemographic and Clinical Data Form" created by the researchers will be completed. For the ADHD diagnosed group, the "Conners Parent Rating Scale - Revised Short" and "Conners Teacher Rating Scale - Revised Short" will be applied to determine the severity of the disorder, symptoms, and predominant subtyping. After the diagnosis is made and evaluated according to the exclusion criteria, blood samples will be taken from the patient after a 10-12 hour fasting period, between 9-12 AM, in a yellow-capped tube, before the routine methylphenidate treatment is used. After waiting for 10-20 minutes at room temperature, the sample will be centrifuged at 3000 RPM for 20 minutes, and the serum will be collected in Eppendorf tubes and stored at -80°C until analysis. After 3 months of treatment, blood samples will be taken again in the same manner and stored. Once all the samples are collected, the serum samples will be analyzed for total antioxidant status (TAS), total oxidant status (TOS), malondialdehyde (MDA), superoxide dismutase (SOD), and oxidized LDL levels according to the human ELISA kit protocols at the Biochemistry Laboratory of Bakırköy Dr. Sadi Konuk Training and Research Hospital by biochemist Dr. Hacer Eroğlu İçli. After 3 months of treatment, the Conners Parent Rating Scale - Revised Short and Conners Teacher Rating Scale - Revised Short forms will be applied again. In addition to the markers, the Oxidative Stress Index (OSI = TOS/TAS) will be calculated and included in the evaluation before and 3 months after the treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient group | – | Other: This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.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
- 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)
- - A diagnosis of "Attention Deficit Hyperactivity Disorder" according to DSM-5 TR, and the initiation or planned initiation of methylphenidate treatment as part of routine care.
- Being between the ages of 6 and 11.
- Providing consent to participate in the study after being informed about the study.
Key exclusion criteria (9 listed)
- - Presence of a psychiatric disorder diagnosis other than "Attention Deficit Hyperactivity Disorder."
- The diagnosis of "Attention Deficit Hyperactivity Disorder" has been made, but methylphenidate treatment has not been planned.
- Being under the age of 6 or over the age of 11.
- Presence of organic brain damage, mental retardation, autism spectrum disorder, neurological diseases, or any physical illness affecting neurocognitive functions.
- A 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.Also: methylphenidate, ADHD treatmentThis is not an interventional study. Patients diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), for whom methylphenidate treatment is planned, have been invited to participate in the study. The patients have been enrolled in follow-up, and our contact information has been provided to them. As part of routine care, patients have been called in once a month. Necessary dosage adjustments have been made in accordance with medical guidelines, without any intervention for the study. Patients with complaints or those who needed to be seen earlier have been seen in between. As a result, the patients were followed for a total of 3 months for this study. Serum samples for oxidative stress markers were collected at baseline (before treatment started) and at the 3rd month (after treatment began). | Other | Patient group |
Primary outcome
Change in Total Oxidant Status
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
Total Oxidant Status (TOS) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. TOS was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1599Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Total Antioxidant Status
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
Total antioxidant status (TAS) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment.TAS was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E4350Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Superoxide Dismutas
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
superoxide dismutas level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. Superoxide dismutas was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E0918Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Malondialdehyde
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
Malondialdehyde (MDA) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. MDA was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1371Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Ox-LDL
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
Ox-LDL level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. Ox-LDL was measured according to the human ELISA kit protocol as follows (bioassay technology laboratory, Cat.No E1521Hu): Standards added to wells. 40μl of serum sample was added to the sample wells, followed by 10μl of anti-TOS 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 Oxidative Stress Index (OSI)
Time frame: Immediately before starting the treatment and up to the 3rd month of treatment.
Oxidative Stress Index (OSI) level was measured according to the human ELISA kit protocol. Serum samples from 39 patients were compared immediately before and after 3 months of treatment. OSI is an index created by the ratio of TOS to TAS. OSI is a parameter that shows the direction in which the body's oxidative stress balance shifts. An increase or decrease in the OSI value indicates that the oxidative balance has changed. While an increase in OSI value indicates a change in balance in favor of oxidants; a decrease in OSI value indicates a change in balance in favor of anti-oxidants.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25933971Smaga I, Niedzielska E, Gawlik M, Moniczewski A, Krzek J, Przegalinski E, Pera J, Filip M. Oxidative stress as an etiological factor and a potential treatment target of psychiatric disorders. Part 2. Depression, anxiety, schizophrenia and autism. Pharmacol Rep. 2015 Jun;67(3):569-80. doi: 10.1016/j.pharep.2014.12.015. Epub 2015 Jan 5.
- Results publication: 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.
- Results publication: 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.
- Results publication: 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.
- Results publication: PubMed 24787685Cunill R, Castells X. [Attention deficit hyperactivity disorder]. Med Clin (Barc). 2015 Apr 20;144(8):370-5. doi: 10.1016/j.medcli.2014.02.025. Epub 2014 Apr 29. Spanish.
- Results publication: 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.
- 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 Hyperactivity Disorder (ADHD), run by Saglik Bilimleri Universitesi 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 8 Jun 2025. 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 8 Jun 2025). 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 Total Oxidant Status (time frame: Immediately before starting the treatment and up to the 3rd month of treatment.). The study lists 6 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 NCT06844812, which also lists 6 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 8 Jun 2025.