ADHD - Attention Deficit Disorder With HyperactivityANIMENCT07417878
Study of the Nutritional, Inflammatory, and Metabolic Endophenotypes of Attention-Deficit/Hyperactivity Disorder (ADHD)
A study testing Clinical and Biological Evaluation - ADHD Cases in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by University Hospital, Montpellier.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD - Attention Deficit Disorder With Hyperactivity
- What is being tested?
- Clinical and Biological Evaluation - ADHD Cases
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2026to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read more
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.
- Being tested
- Clinical and Biological Evaluation - ADHD Cases, Clinical and Biological Evaluation - Controls
- Keywords
- ADHD, Neurodevelopmental Disorders, Psychostimulant, Inflammation, Interleukin-6 (IL-6), Polyphenols, Cytokines
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Neurodevelopmental Disorders, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and Biological Evaluation - ADHD CasesOther
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.
Clinical and Biological Evaluation - ControlsOther
Children and adolescents without psychiatric disorders undergo behavioral and functional questionnaires (P-ARI, R4PDQ, KIDMED)and venous blood sampling for plasma and PBMC analysis.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Other: Clinical and Biological Evaluation - Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (V1)
Secondary outcomes (33)
CRP Levels in ADHD vs. Controls
Comparison of CRP levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
IL-1β Levels in ADHD vs. Controls
Comparison of IL-1β levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
IL-6 Levels in ADHD vs. Controls
Comparison of IL-6 levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
IL-10 Levels in ADHD vs. Controls
Comparison of IL-10 levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
TNF-α Levels in ADHD vs. Controls
Comparison of TNF-α levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
NfL Levels in ADHD vs. Controls
Comparison of NfL levels between ADHD participants and matched controls at V1.
Measured: Baseline (V1)
CRP Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of CRP levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-1β Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of IL-1β levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-6 Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of IL-6 levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-10 Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of IL-10 levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
TNF-α Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of TNF-α levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
NfL Levels in Medicated vs. Unmedicated ADHD Participants
Comparison of NfL levels in ADHD participants during medicated vs. unmedicated periods (V1 vs. V2).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Pro- and Anti-Inflammatory Cytokine Plasma Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Exploration of the existence of distinct immuno-inflammatory profiles among children and adolescents with ADHD using unsupervised clustering methods to define High Inflammatory Profile vs Low Inflammatory Profile. Participants with ADHD will be categorized into distinct biotypes (High Inflammatory vs. Low Inflammatory) determined by the integrated analysis of pro- and anti-inflammatoru cytokines. Plasma levels of IL-6, IL-1β, IL-10, and TNF-α will be measured in pg/mL.
These biomarkers will contribute to the identification of High vs Low inflammatory biotypes using unsupervised clustering methods.
Measured: Baseline (V1)
C-Reactive Protein (CRP) Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Exploration of the existence of distinct immuno-inflammatory profiles among children and adolescents with ADHD using unsupervised clustering methods to define High Inflammatory Profile vs Low Inflammatory Profile. Participants with ADHD will be categorized into distinct biotypes (High Inflammatory vs. Low Inflammatory) determined by the integrated analysis of acute phase reactants. C-reactive protein (CRP) levels will be measured in mg/L.
These biomarkers will contribute to the identification of High vs Low inflammatory biotypes using unsupervised clustering methods.
Measured: Baseline (V1)
Neurofilament Light Chain (NfL) Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Exploration of the existence of distinct immuno-inflammatory profiles among children and adolescents with ADHD using unsupervised clustering methods to define High Inflammatory Profile vs Low Inflammatory Profile. Participants with ADHD will be categorized into distinct biotypes (High Inflammatory vs. Low Inflammatory) determined by the integrated analysis of a neuronal injury marker. Neurofilament Light chain (NfL) levels will be measured in pg/mL.
These biomarkers will contribute to the identification of High vs Low inflammatory biotypes using unsupervised clustering methods.
Measured: Baseline (V1)
Correlations between Immuno-Inflammatory Profiles & ADHD Symptoms
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and ADHD symptoms using the Attention Deficit Hyperactivity Disorder Rating Scale 'ADHD-RS'
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Gastrointestinal Symptoms
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and gastrointestinal symptoms using the Rome IV Pediatric Diagnostic Questionnaire 'R4DQ-child'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Treatment Tolerability/Effectiveness
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and treatment tolerability/effectiveness using the Pediatric Adverse Event Rating Scale 'PAERS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Treatment Tolerability/Effectiveness
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and treatment tolerability/effectiveness using the Visual Analog Scale 'VAS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Irritability
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and irritability using the Parental Affective Reactivity Index 'ARI-P'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Nutritional Profiles in ADHD vs. Controls
Comparison of nutritional profiles assessed using the Mediterranean Diet Quality Index in children and adolescents 'KIDMED' between children and adolescents with ADHD and age- and sex-matched typically developing peers.
Measured: Baseline (V1)
Correlations between Nutritional and Immuno-Inflammatory profiles
Examination of correlations between nutritional profiles - using the Mediterranean Diet Quality Index in children and adolescents 'KIDMED' - and the immuno-inflammatory profiles (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & ADHD symptoms
Examination of correlations of polyphenol bioavailability - using a 3-day food-tracking diary and the Phenol-Explorer database - with ADHD symptoms using the Attention Deficit Hyperactivity Disorder Rating Scale 'ADHD-RS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Irritability
Examination of correlations between polyphenol bioavailability - using a 3-day food-tracking diary and the Phenol-Explorer database - with irritability using the Parental Affective Reactivity Index 'ARI-P').
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Immuno-Inflammatory Markers
Examination of correlations between polyphenol bioavailability - using a 3-day food-tracking diary and the Phenol-Explorer database - with immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL).
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Treatment Tolerability/Effectiveness
Examination of correlations between polyphenol bioavailability - using a 3-day food-tracking diary and the Phenol-Explorer database - with psychostimulant treatment tolerability/effectiveness using the Pediatric Adverse Event Rating Scale 'PAERS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Treatment Tolerability/Effectiveness
Examination of correlations between polyphenol bioavailability - using a 3-day food-tracking diary and the Phenol-Explorer database - with psychostimulant treatment tolerability/effectiveness using the Visual Analog Scale 'VAS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & ADHD Symptoms
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and ADHD symptoms using the Attention Deficit Hyperactivity Disorder Rating Scale 'ADHD-RS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Irritabiliy
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and irritabiliy using the Parental Affective Reactivity Index 'ARI-P'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between immuno-inflammatory markers and ADHD symptoms
Examination of correlations between immuno-inflammatory markers (CRP, IL-6, IL-1β, IL-10, TNF-α, and NfL) and ADHD symptoms using Clinical Global Impression 'CGI'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between nutritional profiles and ADHD symptoms
Examination of correlations between nutritional profiles - using the Mediterranean Diet Quality Index in children and adolescents 'KIDMED' - and clinical symptoms using the Attention Deficit Hyperactivity Disorder Rating Scale 'ADHD-RS'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between nutritional profiles and overall clinical symptoms
Examination of correlations between nutritional profiles - using the Mediterranean Diet Quality Index in children and adolescents 'KIDMED' - and overall clinical symptoms using Clinical Global Impression 'CGI'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & overall clinical symptoms
Examination of correlations of polyphenol bioavailability using a 3-day food-tracking diary and the Phenol-Explorer database with overall clinical symptoms using Clinical Global Impression 'CGI'.
Measured: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ADHD - Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- INRAE Bordeaux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07417878
- Sponsor's protocol ID
- RECHMPL24_0347
- Acronym
- ANIME
- Status last verified
- Jan 2026
- First submitted
- 23 Jan 2026
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 41896813
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Nutritional, Inflammatory, and Metabolic Endophenotypes of Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT07417878
- Acronym / sponsor ID
- ANIME / RECHMPL24_0347
- Keywords
- ADHD, Neurodevelopmental Disorders, Psychostimulant, Inflammation, Interleukin-6 (IL-6), Polyphenols, Cytokines
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- INRAE Bordeaux
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 18 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| ADHD Cases (with or without treatment) | Other | Other: Clinical and Biological Evaluation - ADHD CasesChildren 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). |
| Healthy Controls | Other | Other: Clinical and Biological Evaluation - ControlsAge- and sex-matched children and adolescents without ADHD will be recruited via referrals from cases, local population, and public announcements. |
Who may qualify
- Ages
- 7 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical and Biological Evaluation - ADHD CasesChildren 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. | Other | ADHD Cases (with or without treatment) |
| Clinical and Biological Evaluation - ControlsChildren and adolescents without psychiatric disorders undergo behavioral and functional questionnaires (P-ARI, R4PDQ, KIDMED)and venous blood sampling for plasma and PBMC analysis. | Other | Healthy Controls |
Primary outcome
Circulating IL-6 Levels in ADHD vs. Controls
Time frame: Baseline (V1)
Comparison of IL-6 levels between children and adolescents with ADHD and age- and sex-matched typically developing controls at baseline (V1).
33 secondary outcomes
CRP Levels in ADHD vs. Controls
Time frame: Baseline (V1)
IL-1β Levels in ADHD vs. Controls
Time frame: Baseline (V1)
IL-6 Levels in ADHD vs. Controls
Time frame: Baseline (V1)
IL-10 Levels in ADHD vs. Controls
Time frame: Baseline (V1)
TNF-α Levels in ADHD vs. Controls
Time frame: Baseline (V1)
NfL Levels in ADHD vs. Controls
Time frame: Baseline (V1)
CRP Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-1β Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-6 Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
IL-10 Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
TNF-α Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
NfL Levels in Medicated vs. Unmedicated ADHD Participants
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Pro- and Anti-Inflammatory Cytokine Plasma Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Time frame: Baseline (V1)
C-Reactive Protein (CRP) Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Time frame: Baseline (V1)
Neurofilament Light Chain (NfL) Levels for Immuno-Inflammatory Biotype Identification in ADHD patients
Time frame: Baseline (V1)
Correlations between Immuno-Inflammatory Profiles & ADHD Symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Gastrointestinal Symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Treatment Tolerability/Effectiveness
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Treatment Tolerability/Effectiveness
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Irritability
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Nutritional Profiles in ADHD vs. Controls
Time frame: Baseline (V1)
Correlations between Nutritional and Immuno-Inflammatory profiles
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & ADHD symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Irritability
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Immuno-Inflammatory Markers
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Treatment Tolerability/Effectiveness
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & Treatment Tolerability/Effectiveness
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & ADHD Symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Immuno-Inflammatory Profiles & Irritabiliy
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between immuno-inflammatory markers and ADHD symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between nutritional profiles and ADHD symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between nutritional profiles and overall clinical symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Correlations between Polyphenol Bioavailability & overall clinical symptoms
Time frame: Baseline (V1) and Follow-up (V2)(up to 6-months after V1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
- Derived from this study: PubMed 41896813Fongaro 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.
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RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
RecruitingPhase 3
A Study to Test the Effects of Centanafadine in Adults With Attention-deficit/Hyperactivity Disorder and Emotional Dysregulation
Attention-deficit/Hyperactivity Disorder, Emotional Dysregulation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and Biological Evaluation - ADHD Cases in people with ADHD - Attention Deficit Disorder With Hyperactivity, run by University Hospital, Montpellier.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Diane PURPER-OUAKIL, PUPH (+ 33 467336009 Ext. +33, d-purper_ouakil@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circulating IL-6 Levels in ADHD vs. Controls (time frame: Baseline (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07417878, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2026.