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
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.
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)
University Hospital, Tours
Lead sponsor
Fondation de l'Avenir
Collaborator