Clinical trial

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

Opening soon · Phase 4 · 1 countries · Registry ID NCT07121621

Opening soonPhase 4Interventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to Not listed

SexAll

Healthy volunteersNot accepted

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

Full registry criteria

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

Treatments and study arms

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).

Primary outcomes

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

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Center Hospitalier Régional Universitaire of TOURS🇫🇷 Tours, Indre-et-Loire, France

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Paul BRUNAULT, MD and PhDContact

Email · Call 02 18 37 05 81

Valérie GISSOT, MDContact

Email · Call 02 34 37 96 53