Trial Outcomes & Findings for The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder (NCT NCT07041333)
NCT ID: NCT07041333
Last Updated: 2026-02-24
Results Overview
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.
COMPLETED
57 participants
Immediately before starting the treatment and up to the 3rd month of treatment.
2026-02-24
Participant Flow
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.
Participant milestones
| Measure |
Patient Group
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Overall Study
STARTED
|
57
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
Patient Group
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
|
Overall Study
Side effect
|
3
|
|
Overall Study
Medication refusal by the child.
|
3
|
|
Overall Study
Medication refusal by the family.
|
1
|
|
Overall Study
The family's request to obtain a second medical opinion.
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patient Group
n=42 Participants
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Age, Continuous
|
8.32 years
STANDARD_DEVIATION 1.59 • n=42 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=42 Participants
|
|
Region of Enrollment
Turkey
|
42 participants
n=42 Participants
|
|
kilogram (kg)
|
27.6 kilogram (kg)
STANDARD_DEVIATION 7.22 • n=42 Participants
|
|
Body Mass Index (BMI)
|
16.5 kg/m²
STANDARD_DEVIATION 1.93 • n=42 Participants
|
|
Body Mass Index (BMI) z-score
|
0.13 z-score
STANDARD_DEVIATION 0.84 • n=42 Participants
|
|
Height
|
128 Centimeters (cm)
STANDARD_DEVIATION 0.11 • n=42 Participants
|
|
School year (year(s))
|
2.5 years
n=42 Participants
|
|
ADHD presentation type
Combined presentation
|
29 Participants
n=42 Participants
|
|
ADHD presentation type
Predominantly inattentive presentation
|
9 Participants
n=42 Participants
|
|
ADHD presentation type
Predominantly hyperactive-impulsive presentation
|
4 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.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.
Outcome measures
| Measure |
Patient Group
n=42 Participants
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Change in IL-6 Marker Level
IL-6 (before starting treatment)
|
113.89 ng/L
Standard Deviation 121.27
|
|
Change in IL-6 Marker Level
IL-6 (after starting treatment)
|
103.45 ng/L
Standard Deviation 101.62
|
PRIMARY outcome
Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.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.
Outcome measures
| Measure |
Patient Group
n=42 Participants
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Change in S100B Marker Level
S100B (before starting treatment)
|
871.13 ng/L
Interval 582.27 to 1185.95
|
|
Change in S100B Marker Level
S100B (after starting treatment)
|
758.13 ng/L
Interval 507.67 to 1031.77
|
PRIMARY outcome
Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.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.
Outcome measures
| Measure |
Patient Group
n=42 Participants
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
Change in the Level of Claudin-5 Marker
Claudin 5 (before starting treatment)
|
206.52 ng/L
Interval 118.29 to 473.93
|
|
Change in the Level of Claudin-5 Marker
Claudin 5 (after starting treatment)
|
181.76 ng/L
Interval 124.32 to 367.88
|
Adverse Events
Patient Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Patient Group
n=57 participants at risk
Patient group with attention deficit and hyperactivity disorder. The group planned to start methylphenidate treatment independent of the study
|
|---|---|
|
General disorders
loss of appetite
|
38.6%
22/57 • 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
|
1.8%
1/57 • 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
|
5.3%
3/57 • 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
Dizziness
|
1.8%
1/57 • 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
|
7.0%
4/57 • 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
|
7.0%
4/57 • 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
Agitation
|
1.8%
1/57 • 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
Extreme stagnation
|
12.3%
7/57 • 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
Chest pain
|
1.8%
1/57 • 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
Tachycardia
|
1.8%
1/57 • 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
Difficulty falling asleep at night
|
7.0%
4/57 • 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
Blurred vision
|
1.8%
1/57 • 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
Prof. Dr. Mazhar Osman Mental Health and Neurological Diseases Training and Research Hospital
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place