Trial Outcomes & Findings for The Effect of Methylphenidate Treatment on Oxidative Stress Levels in Children Diagnosed With Attention Deficit Hyperactivity Disorder (ADHD) (NCT NCT06844812)
NCT ID: NCT06844812
Last Updated: 2025-06-08
Results Overview
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.
COMPLETED
39 participants
Immediately before starting the treatment and up to the 3rd month of treatment.
2025-06-08
Participant Flow
Initially, 39 patients were enrolled in the study, and each patient who dropped out of the study during follow-up was replaced by a new patient in accordance with the protocol. Thus, a total of 53 patients were included in the study and 14 patients left the study for various reasons.
Participant milestones
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
Patients diagnosed with attention deficit hyperactivity and planned to start methylphenidate treatment
|
|---|---|
|
Overall Study
STARTED
|
53
|
|
Overall Study
COMPLETED
|
39
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
Patients diagnosed with attention deficit hyperactivity and planned to start methylphenidate treatment
|
|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
|
Overall Study
stigmatization concerns
|
2
|
|
Overall Study
medication refusal
|
2
|
|
Overall Study
concerns about possible side effects
|
2
|
|
Overall Study
wanting to seek another specialist opinion
|
2
|
|
Overall Study
side effects (dizziness)
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Patients diagnosed with attention deficit hyperactivity and planned to start methylphenidate treatment
|
|---|---|
|
Age, Continuous
|
8.38 years
STANDARD_DEVIATION 1.11 • n=39 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=39 Participants
|
|
Region of Enrollment
Turkey
|
39 participants
n=39 Participants
|
|
Body Weight
|
27.95 kilogram (kg)
STANDARD_DEVIATION 7.38 • n=39 Participants
|
|
body mass index (BMI)
|
16.60 kilogram(kg)/height(metre)²
STANDARD_DEVIATION 1.96 • n=39 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Total Oxidant Status
total oxidant status (before starting treatment)
|
6.29 U/ml
Standard Deviation 5.37
|
|
Change in Total Oxidant Status
total oxidant status (after starting treatment)
|
5.62 U/ml
Standard Deviation 4.76
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Total Antioxidant Status
total antioxidant status (before starting treatment)
|
7.79 U/ml
Standard Deviation 5.65
|
|
Change in Total Antioxidant Status
total antioxidant status (after starting treatment)
|
7.33 U/ml
Standard Deviation 5.40
|
PRIMARY outcome
Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.Population: 2 patients were excluded because there was no reaction and no color change in the measurement.
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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=37 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Superoxide Dismutas
superoxide dismutas (before starting treatment
|
175.89 U/L
Standard Deviation 158.95
|
|
Change in Superoxide Dismutas
superoxide dismutas (after starting treatment)
|
160.88 U/L
Standard Deviation 143.49
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Malondialdehyde
Malondialdehyde (before starting treatment)
|
9.58 nmol/ml
Interval 7.35 to 9.94
|
|
Change in Malondialdehyde
Malondialdehyde (after starting treatment)
|
8.65 nmol/ml
Interval 7.0 to 13.61
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Ox-LDL
Ox-LDL (before starting treatment)
|
34.19 ng/mL
Interval 26.36 to 60.96
|
|
Change in Ox-LDL
Ox-LDL (after starting treatment)
|
29.59 ng/mL
Interval 25.24 to 56.67
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=39 Participants
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
Change in Oxidative Stress Index (OSI)
Oxidative Stress Index (OSI) (before starting treatment)
|
0.75 Index
Standard Deviation 0.12
|
|
Change in Oxidative Stress Index (OSI)
Oxidative Stress Index (OSI) (after starting treatment)
|
0.72 Index
Standard Deviation 0.12
|
Adverse Events
Patients Diagnosed With Attention Deficit Hyperactivity
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patients Diagnosed With Attention Deficit Hyperactivity
n=53 participants at risk
Children aged 6 to 11 years with attention deficit hyperactivity
|
|---|---|
|
General disorders
loss of appetite
|
37.7%
20/53 • 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.
|
|
General disorders
abdominal pain (temporary)
|
9.4%
5/53 • 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.
|
|
General disorders
headache (temporary)
|
5.7%
3/53 • 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.
|
|
General disorders
nausea (temporary)
|
9.4%
5/53 • 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.
|
|
General disorders
stagnation (temporary)
|
11.3%
6/53 • 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.
|
|
General disorders
weight loss
|
5.7%
3/53 • 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.
|
Additional Information
Dr. Enes Faruk ALTUNKILIÇ
mazhar osman mental and nervous diseases hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place