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NOT YET RECRUITING
NCT07121621
PHASE4

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

Sponsor: University Hospital, Tours

View on ClinicalTrials.gov

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

Official title: PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder: Comparison Between Patients With and Without OBesity

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2025-09-01

Completion Date

2026-09-02

Last Updated

2025-08-13

Healthy Volunteers

No

Interventions

DRUG

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

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).

Locations (1)

Center Hospitalier Régional Universitaire of TOURS

Tours, Indre-et-Loire, France