NCT07121621Not yet recruitingPhase 4
PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder
PHArmaCokinetics of methYLphenidate in Adult Patients With Attention-Deficit /Hyperactivity Disorder: Comparison Between Patients With and Without OBesity
Source: ClinicalTrials.gov · Last updated 13 Aug 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 6 Aug 2025
- Start date
- 1 Sept 2025
- Primary completion date
- 2 Sept 2026
- Lead sponsor
- University Hospital, Tours
- Diseases
- Obesity
- NCT number
- NCT07121621
- EU CT number
- 2024-519461-22-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Sept 2025 to the primary completion date, 2 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior 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.
- Known prior renal impairment
Other illness
- Severe cognitive impairment (clinical evaluation)
- Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)
Age
- Female patients of childbearing age without at least one acceptable contraceptive method (see definition in Appendix 1)
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Center Hospitalier Régional Universitaire of TOURS Coordinator of this site? Confirm its status | Tours | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.