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

Launched by UNIVERSITY HOSPITAL, TOURS · Aug 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how the body absorbs and processes a medicine called methylphenidate, which is commonly used to treat adults with Attention Deficit Hyperactivity Disorder (ADHD). The researchers want to find out if the way this medicine works in the body is different for adults with ADHD who are obese (have a body mass index, or BMI, of 30 or higher) compared to those who are not obese. To do this, they will measure the levels of the medicine in the blood at several times throughout the day after taking a usual dose, to see if the amount changes differently depending on a person’s weight.

Adults aged 18 and older who have been diagnosed with ADHD and have been taking a stable dose of methylphenidate for at least two weeks may be able to join. Participants will be grouped based on their BMI to compare those with obesity and those without. During the study, blood samples will be taken before and several times after medication is taken to check how the drug moves through the body. The trial is not yet recruiting, and people who have certain health conditions or are pregnant may not be eligible. If you qualify and take part, you’ll help researchers understand if weight affects how ADHD medication works, which could lead to better, more personalized treatments in the future.

Gender

ALL

Eligibility 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