PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder

NCT07121621 | Not Yet Recruiting Phase 4

• 2 other identifiers: DR2403052024-519461-22-00
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity. Its aim is to determine whether, for a comparable treatment dose, there are differences in the pharmacokinetic of methylphenidate between ADHD patients with obesitý and ADHD patients but without obesitý. More specifically, we will assess whether blood concentrations of methylphenidate (MPH; long acting form) are significantly higher or lower in either group at different times of the day. To meet this objective, we are conducting this pharmacokinetic clinical trial with blood sampling and repeated clinical measurements just prior to MPH administration (= at T0) and then, at different times after administration, i.e. at times (T): T 30 minutes, T 1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration. As far as MPH is concerned, this is the usual treatment. However, we may hypothesize that the distribution in the body may differ according to weight: hence the interest of this study

Conditions

Attention Deficit Hyperactivity Disorder (ADHD); Obesity (Body Mass Index &Amp;Amp;gt;30 kg/m2); Methylphenidate; Obesity &Amp; Overweight

Keywords

Methylphenidate; Attention Deficit Hyperactivity Disorder (ADHD); Obesity; Pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.

  The primary endpoint is the area under the curve (AUC) of blood concentrations of MPH and APP, its active metabolite, measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration, compared between patients with and without obesity.

  Anticipated recruitment period: 12 months / Duration of each subject's participation: 1 day / Total duration of research: 12 months and 1 day

Study Arms (1)

PHArmacoKinetics of methYLphenidate in adult patients with ADHD

EXPERIMENTAL

PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients with OBesity. PHArmacoKinetics of methYLphenidate in adult patients with ADHD: patients without OBesity.

Drug: PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity.

Interventions

PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity. DRUG

The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning. Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI\<30 kg/m2).

PHArmacoKinetics of methYLphenidate in adult patients with ADHD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 and over
• Diagnosis of ADHD by a psychiatrist, based on DSM-5 criteria (ADHD mixed form, predominantly inattentive or predominantly hyperactive/impulsive)
• Treatment with methylphenidate LP (Ritaline) with a stable dosage for at least two weeks.
• Participant affiliated to a social security scheme
• Written consent signed by participant

You may not qualify if:

• Contraindications to methylphenidate treatment
• Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant.
• Treatment with a proton pump inhibitor within the last 2 weeks.
• Severe cognitive impairment (clinical evaluation)
• Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)
• Known prior renal impairment
• Pregnant or breast-feeding women
• Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1)
• Patients under legal protection
• Inability of the patient to self-assess the intensity of ADHD symptoms

Sponsors & Collaborators

• University Hospital, Tours: lead
• Fondation de l'Avenir: collaborator

Study Sites (1)

Center Hospitalier Régional Universitaire of TOURS

Tours, Indre-et-Loire, 37044, France

Location

Related Publications (2)

• Faraone SV, Banaschewski T, Coghill D, Zheng Y, Biederman J, Bellgrove MA, Newcorn JH, Gignac M, Al Saud NM, Manor I, Rohde LA, Yang L, Cortese S, Almagor D, Stein MA, Albatti TH, Aljoudi HF, Alqahtani MMJ, Asherson P, Atwoli L, Bolte S, Buitelaar JK, Crunelle CL, Daley D, Dalsgaard S, Dopfner M, Espinet S, Fitzgerald M, Franke B, Gerlach M, Haavik J, Hartman CA, Hartung CM, Hinshaw SP, Hoekstra PJ, Hollis C, Kollins SH, Sandra Kooij JJ, Kuntsi J, Larsson H, Li T, Liu J, Merzon E, Mattingly G, Mattos P, McCarthy S, Mikami AY, Molina BSG, Nigg JT, Purper-Ouakil D, Omigbodun OO, Polanczyk GV, Pollak Y, Poulton AS, Rajkumar RP, Reding A, Reif A, Rubia K, Rucklidge J, Romanos M, Ramos-Quiroga JA, Schellekens A, Scheres A, Schoeman R, Schweitzer JB, Shah H, Solanto MV, Sonuga-Barke E, Soutullo C, Steinhausen HC, Swanson JM, Thapar A, Tripp G, van de Glind G, van den Brink W, Van der Oord S, Venter A, Vitiello B, Walitza S, Wang Y. The World Federation of ADHD International Consensus Statement: 208 Evidence-based conclusions about the disorder. Neurosci Biobehav Rev. 2021 Sep;128:789-818. doi: 10.1016/j.neubiorev.2021.01.022. Epub 2021 Feb 4.

  PMID: 33549739 BACKGROUND

• Brunault P, Frammery J, Montaudon P, De Luca A, Hankard R, Ducluzeau PH, Cortese S, Ballon N. Adulthood and childhood ADHD in patients consulting for obesity is associated with food addiction and binge eating, but not sleep apnea syndrome. Appetite. 2019 May 1;136:25-32. doi: 10.1016/j.appet.2019.01.013. Epub 2019 Jan 11.

  PMID: 30641157 BACKGROUND

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity; Obesity; Overweight

Interventions

Adiposity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Body Fat Distribution; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Body Composition; Biochemical Phenomena; Chemical Phenomena; Metabolism; Physiological Phenomena

Central Study Contacts

Paul BRUNAULT, MD and PhD

CONTACT

02 18 37 05 81; paul.brunault@univ-tours.fr

Valérie GISSOT, MD

CONTACT

02 34 37 96 53; valerie.gissot@univ-tours.fr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The pharmacological intervention, which will be the same for all patients in the study, will consist in administering MPH at CIC 1415 (URHC of Tours) in the form of Prolonged Release at the patient's usual dosage, in the early morning. Compare the total area under the curve (AUC) of MPH and alpha-phenyl 2 piperidine acid (APP), its active metabolite, between patients with ADHD and obesity and patients with ADHD but without obesity. Pharmacokinetic study with repeated measurements at T0 (just before MPH administration) then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h (8 measurements) after MPH administration, in 15 patients with ADHD and obesity (BMI≥30 kg/m2) and in 15 patients with ADHD but without obesity (BMI\<30 kg/m2).

Study Record Dates

• First Submitted: August 6, 2025
• First Posted: August 13, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 2, 2026
• Study Completion (Estimated): September 2, 2026
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)