N/A
N=53
The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD)
Attention Deficit Hyperactivity Disorder (ADHD)
Bottom Line
View on ClinicalTrials.gov: NCT06844812 ↗Enrolled (actual)
53
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Total Oxidant Status — 6.29; 5.62 U/ml — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- This is not an interventional study. Patients who are planned to start methylphenidate treatment have been invited to participate in the study. (Other)
- Age
- Pediatric · 6+ yrs
- Sex
- All
- Sponsor
- Saglik Bilimleri Universitesi
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Oxidant Status |
6.29; 5.62 | <0.001 sig |
| PRIMARY Change in Total Antioxidant Status |
7.79; 7.33 | 0.021 sig |
| PRIMARY Change in Superoxide Dismutas |
175.89; 160.88 | 0.003 sig |
| PRIMARY Change in Malondialdehyde |
9.58; 8.65 | <0.001 sig |
| PRIMARY Change in Ox-LDL |
34.19; 29.59 | 0.001 sig |
| PRIMARY Change in Oxidative Stress Index (OSI) |
0.75; 0.72 | — |
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.
Eligibility Criteria
Inclusion Criteria
- - 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.
Exclusion Criteria
- - 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.
Data sourced from ClinicalTrials.gov (NCT06844812). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.