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

Study acronym: PHACYLOB
StatusNot Yet Recruiting
PhasePhase 4
Started2025-09-01
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Record status
This record was last updated August 13, 2025 (before its estimated September 2, 2026 completion). Its status may not reflect the trial's current state.
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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
Trial Details
NCT Number NCT07121621
Lead Sponsor University Hospital, Tours
Collaborators: Fondation de l'Avenir
Conditions Attention Deficit Hyperactivity Disorder (ADHD), Obesity (Body Mass Index >30 kg/m2), Methylphenidate, Obesity & Overweight
Enrollment 30 participants
Start Date 2025-09-01
Primary Completion 2026-09-02 (estimated)
Study Completion 2026-09-02 (estimated)
Updated on ClinicalTrials.gov 2025-08-13