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PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity_PHACYLOB.
EU CTIS ID: 2024-519461-22-00
What this study is testing
Compare the total area under the curve of MPH and its active metabolite, alpha-phenyl 2-piperidine acid, between patients with ADHD and obesity and patients with ADHD but without obesity.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age greater than or equal to 18 years
- Diagnosis of ADHD by referring clinician, DSM-5 criteria (mixed form ADHD, predominantly inattentive or predominantly hyperactive/impulsive)
- Treatment with Ritalin LP with 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 the participant
You likely can't join if
- Contraindications to methylphenidate treatment (see pharmacological aspects below)
- Patients under legal protection
- Patient's inability to self-assess the intensity of ADHD symptoms
- 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)
See the full eligibility criteria
- Age greater than or equal to 18 years
- Diagnosis of ADHD by referring clinician, DSM-5 criteria (mixed form ADHD, predominantly inattentive or predominantly hyperactive/impulsive)
- Treatment with Ritalin LP with 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 the participant
- Contraindications to methylphenidate treatment (see pharmacological aspects below)
- Patients under legal protection
- Patient's inability to self-assess the intensity of ADHD symptoms
- 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)
- Current use of at least one illicit substance (e.g. cannabis, opiates, cocaine)
- Known renal impairment documented in pre-treatment work-up (eDFG <30 ml/min/1.73m2)
- Pregnant or breast-feeding women
- Patient of childbearing age without at least one acceptable contraceptive method (see definition in appendix 1)
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.