Checks how methylphenidate moves through the body in adults with ADHD and obesity
Tests methylphenidate levels in adults with ADHD, with and without obesity.
Plain-language title generated from the registry record
Registry title: PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder
Key facts
- Where
- Tours, FranceSee the site
- Phase
- Phase 4
Where in France
- Center Hospitalier Régional Universitaire of TOURSTours, FranceNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital, Tours
- Trial code
- NCT07121621EU 2024-519461-22-00
- Record updated
- 13 August 2025
- Original description
PHACYLOB PHArmaCokinetics of methYLphenidate in adult patients with Attention-Deficit Hyperactivity Disorder (ADHD) : comparison between patients with and without OBesity.Read full original descriptionShow less
PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder: Comparison Between Patients With and Without OBesity
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
Inclusion: 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: 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; Known prior renal impairment; Severe cognitive impairment (clinical evaluation); Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation); Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1); Contraindications to methylphenidate treatment; Pregnant or breast-feeding women; Patients under legal protection; Inability of the patient to self-assess the intensity of ADHD symptoms.