The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)

NCT06844812 | Completed Results

• 1 other identifier: 2024-05-27
• Study Type: observational
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Keywords

methylphenidate; Attention Deficit Hyperactivity Disorder; ADHD; oxidative stress

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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.

  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.

  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.

  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

Other: This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study.

Interventions

This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study. OTHER

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).

Also known as: methylphenidate, ADHD treatment

Patient group

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• 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:

• \- 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.

You may not qualify if:

• \- 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.
• Previous use of psychiatric medication.
• Presence of a chronic illness.
• Use of regular medication.

Sponsors & Collaborators

• Saglik Bilimleri Universitesi: lead

Study Sites (1)

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

Istanbul, Bakirkoy, 34147, Turkey (Türkiye)

Location

Related Publications (6)

• 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.

  PMID: 25933971 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 RESULT

• 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 RESULT

• 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 RESULT

• Cunill 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.

  PMID: 24787685 RESULT

• 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 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Enes Faruk ALTUNKILIÇ
• Organization: mazhar osman mental and nervous diseases hospital

enesfarukaltunkilic@gmail.com

+905077362191

Publication Agreements

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: February 25, 2025
• Study Start: June 26, 2024
• Primary Completion: January 6, 2025
• Study Completion: January 6, 2025
• Last Updated: June 8, 2025
• Results First Posted: June 8, 2025

Record last verified: 2025-05

Data Sharing

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

Locations

TU (1)