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

NCT07417878 | Not Yet Recruiting DMC

• 1 other identifier: RECHMPL24_0347
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

ADHD - Attention Deficit Disorder With Hyperactivity

Keywords

ADHD; Neurodevelopmental Disorders; Psychostimulant; Inflammation; Interleukin-6 (IL-6); Polyphenols; Cytokines

Outcome Measures

Primary Outcomes (1)

• Circulating IL-6 Levels in ADHD vs. Controls

  Comparison of IL-6 levels between children and adolescents with ADHD and age- and sex-matched typically developing controls at baseline (V1).

  Baseline (V1)

Secondary Outcomes (33)

• CRP Levels in ADHD vs. Controls

  Baseline (V1)

• IL-1β Levels in ADHD vs. Controls

  Baseline (V1)

• IL-6 Levels in ADHD vs. Controls

  Baseline (V1)

• IL-10 Levels in ADHD vs. Controls

  Baseline (V1)

• TNF-α Levels in ADHD vs. Controls

  Baseline (V1)

Study Arms (2)

ADHD Cases (with or without treatment)

OTHER

Children and adolescents aged 7-17 years diagnosed with ADHD will be recruited from MPEA 1, Montpellier University Hospital. Each participant will undergo two visits: one during stabilized medication and one during treatment interruption (minimum two-week washout).

Other: Clinical and Biological Evaluation - ADHD Cases

Healthy Controls

OTHER

Age- and sex-matched children and adolescents without ADHD will be recruited via referrals from cases, local population, and public announcements.

Other: Clinical and Biological Evaluation - Controls

Interventions

Clinical and Biological Evaluation - ADHD Cases OTHER

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 period to reduce confounding factors.

ADHD Cases (with or without treatment)

Clinical and Biological Evaluation - Controls OTHER

Children and adolescents without psychiatric disorders undergo behavioral and functional questionnaires (P-ARI, R4PDQ, KIDMED)and venous blood sampling for plasma and PBMC analysis.

Healthy Controls

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Signed informed consent obtained from parents or legal guardians.
• Assent obtained from the minor participant.
• Affiliation with a national health insurance system.
• 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.

You may not qualify if:

• 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.
• Presence of an immunological or chronic inflammatory disease.
• Absence of parental consent.
• Absence of assent from the minor participant.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• INRAE Bordeaux: collaborator

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Neurodevelopmental Disorders; Inflammation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Diane PURPER-OUAKIL, PUPH

CONTACT

+ 33 467336009 Ext. +33; d-purper_ouakil@chu-montpellier.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Our study is monocentric and has both descriptive and analytical aims. It includes two complementary study designs to address the different objectives: 1. A Case-Control study aimed at characterizing the nutritional, immune, and inflammatory profiles of children and adolescents with ADHD compared with age- and sex-matched controls, and examining their association with ADHD and gastrointestinal symptomatology. 2. A prospective cohort study proposed to the cases. This cohort of children and adolescents with ADHD will be followed for up to 12 months and assessed twice according to their medication status: V1 (during ongoing psychostimulant treatment) and V2 (during the annual medication break).

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: February 18, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 18, 2026

Record last verified: 2026-01