MedTrace Logo

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

NCT07121621 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-08-13

No results posted yet for this study

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

Conditions

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

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).

Sponsors & Collaborators

  • Fondation de l'Avenir

    collaborator OTHER

  • University Hospital, Tours

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2026-09-02
Completion
2026-09-02

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07121621 on ClinicalTrials.gov