Inflammatory and immune profiling in children and adolescents with attention-deficit/hyperactivity disorder (ADHD): a matched case–control study with longitudinal on/off psychostimulant assessment (ANIME)
Abstract
Background Attention-Deficit/Hyperactivity Disorder (ADHD) is a prevalent neurodevelopmental condition with high societal impact. While psychostimulants like methylphenidate (MPH) are first-line treatments, 10–20% of patients show insufficient efficacy, and many experience side effects such as sleep and appetite disturbances. Emerging evidence suggests that neuroinflammation and oxidative stress contribute to ADHD pathophysiology. Animal studies indicate that MPH may induce pro-inflammatory processes, but this has yet to be characterized in humans. Methods The ANIME study (ADHD Nutritional, Inflammatory, and Metabolic Endophenotypes) employs a combined case-control and prospective cohort design. A case-control study will compare the immune, inflammatory, and nutritional profiles of 40 children/adolescents with ADHD against 40 age- (± 2 years) and sex-matched typically developing controls. The ADHD group will have a follow-up visit to assess the impact of psychostimulant treatment). The primary outcome is the comparison of the immune and inflammatory markers’ levels, particularly IL-6 levels, at baseline. Secondary outcomes include deep immunophenotyping via spectral flow cytometry (Cytek Aurora) and high-sensitivity multiplex proteomics (NULISA), alongside assessments of polyphenol bioavailability, diet quality (KIDMED), and clinical symptoms. Discussion ANIME will provide an in-depth characterization of the “inflammatory biotype” in ADHD, specifically examining how…
How strong is the evidence?
Evidence Hub reads this as a case-control, done in people. Its evidence level is 4 of 5 (Low · observational). Observational designs can show an association but not prove cause. Reported size: 40 participants or records.
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