Not Yet RecruitingPhase 4

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

France30 participantsStarted 2025-09-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion Criteria: * 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. * BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg/m2; (2) for non-obese group: BMI \< 30 kg/m2. * Participant affiliated to a social security scheme * Written consent signed by participant Exclusion Criteria: * 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

What they're measuring

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.

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

Trial details

NCT IDNCT07121621

SponsorUniversity Hospital, Tours

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09-02

Contact for this trial

Paul BRUNAULT, MD and PhD

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

View on ClinicalTrials.gov More Attention Deficit Hyperactivity Disorder (ADHD) trials