Study of the Nutritional, Inflammatory, and Metabolic Endophenotypes of Attention-Deficit/Hyperactivity Disorder (ADHD)

Обзор

This study aims to better understand the biological mechanisms involved in attention deficit hyperactivity disorder (ADHD) and to clarify why some children and adolescents respond well to methylphenidate (MPH)-the most commonly prescribed medication-while others do not. Although MPH is effective for many patients, a significant number experience limited benefits or problematic side effects such as appetite loss and sleep difficulties. Recent research suggests that inflammation and oxidative stress in the body may play an important role in ADHD. Some animal studies also indicate that MPH itself might trigger inflammatory processes, but this has never been examined directly in humans. The main goal of this research is to determine whether children with ADHD show differences in their nutritional, immune, and inflammatory profiles compared to children without ADHD, and whether these biological factors influence symptom severity, digestive problems, and response to treatment. The study also seeks to understand whether MPH has a measurable inflammatory effect in young patients and whether this could be linked to treatment tolerability. To answer these questions, the study combines several approaches. First, a case-control comparison will examine differences between children/adolescents with ADHD and age- and sex-matched controls. Second, a one-year follow-up of the ADHD group will evaluate changes over time and help identify biological predictors of treatment response and side effects. Finally, a cross-sectional analysis will investigate the role of polyphenols-natural antioxidant compounds found in food-in relation to inflammation, treatment outcomes, and gender differences. The primary focus is on comparing levels of the inflammatory marker IL-6 between children with ADHD and controls. Secondary objectives include assessing additional inflammatory and immune indicators, nutritional status, gastrointestinal symptoms, ADHD severity, irritability, and MPH tolerability. By identifying specific inflammatory and immune markers associated with ADHD and treatment response, this study hopes to improve understanding of the disorder and guide more personalized and effective treatment strategies for young patients. It will also provide the first human data on whether psychostimulant medications may have inflammatory effects.

Вмешательства

• Другое Clinical and Biological Evaluation - ADHD Cases
  Children and adolescents with ADHD undergo diagnostic confirmation (K-SADS if not completed within 6 months), behavioral and functional questionnaires (ADHD-RS for cases only, P-ARI, R4PDQ, KIDMED), clinician-rated scales (CGI-S/I, PAERS), and venous blood sampling for plasma and PBMC analysis. They complete two assessments: one during stabilized medication and one after a minimum two-week medication interruption, consistent with clinical practice guidelines. Assessments occur during the school
• Другое Clinical and Biological Evaluation - Controls
  Children and adolescents without psychiatric disorders undergo behavioral and functional questionnaires (P-ARI, R4PDQ, KIDMED)and venous blood sampling for plasma and PBMC analysis.

Первичные конечные точки

• Circulating IL-6 Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]

Вторичные конечные точки (12)

• CRP Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• IL-1β Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• IL-6 Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• IL-10 Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• TNF-α Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• NfL Levels in ADHD vs. Controls [Срок оценки: Baseline (V1)]
• CRP Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]
• IL-1β Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]
• IL-6 Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]
• IL-10 Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]
• TNF-α Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]
• NfL Levels in Medicated vs. Unmedicated ADHD Participants [Срок оценки: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)]

Критерии участия

ADHD Group (Cases) - Inclusion Criteria:

• Children or adolescents aged 7 to 17 years.
• Meet DSM-5 diagnostic criteria for Attention-Deficit/Hyperactivity Disorder (ADHD), assessed using the K-SADS interview.
• Currently treated with psychostimulant medication.
• Stabilized on psychostimulant treatment for at least one month prior to inclusion.
• Signed informed consent obtained from parents or legal guardians.
• Assent obtained from the minor participant.
• Affiliation with a national health insurance system.

Control Group (Typically Developing Peers) - Inclusion Criteria:

• Children or adolescents aged 7 to 17 years without any diagnosed mental disorder.
• Age- and sex-matched with the ADHD group.
• Signed informed consent obtained from parents or legal guardians.
• Assent obtained from the minor participant.
• Affiliation with a national health insurance system.

ADHD Group (Cases) - Exclusion Criteria:

• Presence of a progressive neurological disorder, intellectual developmental disorder, or clinically significant suicide risk.
• Presence of an immunological or chronic inflammatory disease.
• Inability to comply with medication-free periods of at least two weeks.
• Absence of parental consent.
• Absence of assent from the minor participant.
• Participation in another clinical study with an ongoing exclusion period.

Control Group (Typically Developing Peers) - Exclusion Criteria:

• Presence of an immunological or chronic inflammatory disease.
• Absence of parental consent.
• Absence of assent from the minor participant.
• Participation in another clinical study with an ongoing exclusion period.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Fongaro E, Leyrolle Q, Madore C, Lehmann S, Picot MC, Laye S, Purper-Ouakil D. 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). BMC Psychiatry. 2026 Mar 27;26(1):370. doi: 10.1186/s12888-026-08012-1. PMID 41896813

Идентификаторы

NCT: NCT07417878 · RECHMPL24_0347

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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