CompletedNot Applicable

The Effect Of Methylphenıdate Treatment On Neuroınflammatıon Levels In Chıldren Wıth Attentıon Defıcıt Hyperactıvıty Dısorder

Turkey (Türkiye)57 participantsStarted 2025-07-14

Plain-language summary

The aim of this study was to investigate the effect of treatment of ADHD with methylphenidate on neuroinflammation by examining the levels of Interleukin-6 (IL-6), S100B, Claudin-5 in serum samples of patients who were diagnosed with attention deficit hyperactivity disorder (ADHD) and started or planned to start methylphenidate for treatment as per routine, at month 0 before the initiation of methylphenidate treatment and at month 3 after the initiation of treatment.

Who can participate

Age range6 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. According to DSM-5 TR, the participant must have a diagnosis of "Attention Deficit Hyperactivity Disorder" and have started/be planning to start routine methylphenidate treatment.
✓. The participant must be between 6 and 11 years of age.
✓. The participant must agree to participate in the study after being informed about it.

Exclusion criteria

✕. The presence of a psychiatric disorder diagnosis other than Attention Deficit Hyperactivity Disorder
✕. Having a diagnosis of Attention Deficit Hyperactivity Disorder but not planning to start methylphenidate
✕. Being under 6 years of age or over 11 years of age
✕. Having organic brain damage, mental retardation, autism spectrum disorder, neurological disease, or a physical illness that affects neurocognitive functions
✕. History of alcohol and/or psychoactive substance use
✕. Presence of ongoing active infection, allergic disease, and chronic illness
✕. Previous use of psychiatric medication.
✕. Presence of chronic illness

What they're measuring

Change in IL-6 Marker Level

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.

Change in S100B Marker Level

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.

Change in the Level of Claudin-5 Marker

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.

Trial details

NCT IDNCT07041333

SponsorEnes Faruk ALTUNKILIÇ

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-10-19

Results submitted2026-01-11

View on ClinicalTrials.gov More Attention Deficit Disorder With Hyperactivity (ADHD) trials

Plain-language summary

Who can participate

Age range6 Years – 11 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. According to DSM-5 TR, the participant must have a diagnosis of "Attention Deficit Hyperactivity Disorder" and have started/be planning to start routine methylphenidate treatment.
✓. The participant must be between 6 and 11 years of age.
✓. The participant must agree to participate in the study after being informed about it.

Exclusion criteria

✕. The presence of a psychiatric disorder diagnosis other than Attention Deficit Hyperactivity Disorder
✕. Having a diagnosis of Attention Deficit Hyperactivity Disorder but not planning to start methylphenidate
✕. Being under 6 years of age or over 11 years of age
✕. Having organic brain damage, mental retardation, autism spectrum disorder, neurological disease, or a physical illness that affects neurocognitive functions
✕. History of alcohol and/or psychoactive substance use
✕. Presence of ongoing active infection, allergic disease, and chronic illness
✕. Previous use of psychiatric medication.
✕. Presence of chronic illness

What they're measuring

Change in IL-6 Marker Level

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.

Change in S100B Marker Level

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.

Change in the Level of Claudin-5 Marker

Timeframe: Immediately before starting the treatment and up to the 3rd month of treatment.