Methylphenidate hydrochloride for Attention deficit hyperactivity disorder (ADHD) | Obesity

Inclusion criteria

• {"criterion_text":"- Age greater than or equal to 18 years"}
• {"criterion_text":"- Diagnosis of ADHD by referring clinician, DSM-5 criteria (mixed form ADHD, predominantly inattentive or predominantly hyperactive/impulsive)"}
• {"criterion_text":"- Treatment with Ritalin LP with stable dosage for at least two weeks"}
• {"criterion_text":"- BMI inclusion criteria: (1) for obese group: BMI ≥ 30 kg/m2; (2) for non-obese group: BMI < 30 kg/m2"}
• {"criterion_text":"- Participant affiliated to a social security scheme"}
• {"criterion_text":"- Written consent signed by the participant"}

Exclusion criteria

• {"criterion_text":"- Contraindications to methylphenidate treatment (see pharmacological aspects below)"}
• {"criterion_text":"- Patients under legal protection"}
• {"criterion_text":"- Patient's inability to self-assess the intensity of ADHD symptoms"}
• {"criterion_text":"- Treatment with an oral or nasal decongestant vasoconstrictor; association with a non-selective MAOI antidepressant"}
• {"criterion_text":"- Treatment with a proton pump inhibitor within the last 2 weeks"}
• {"criterion_text":"- Severe cognitive impairment (clinical evaluation)"}
• {"criterion_text":"- Severe alcohol use disorder, i.e. at least 6 DSM-5 criteria for substance use disorder (clinical evaluation)"}
• {"criterion_text":"- Current use of at least one illicit substance (e.g. cannabis, opiates, cocaine)"}
• {"criterion_text":"- Known renal impairment documented in pre-treatment work-up (eDFG <30 ml/min/1.73m2)"}
• {"criterion_text":"- Pregnant or breast-feeding women"}
• {"criterion_text":"- Patient of childbearing age without at least one acceptable contraceptive method (see definition in appendix 1)"}

Primary endpoints

• {"endpoint_text":"- The primary endpoint was the area under the curve of blood concentrations of MPH and its active metabolite (alpha-phenyl 2-piperidine acid), as measured at different times after administration and up to 8 hours after MPH administration (comparison between patients with and without obesity): T0, T30 minutes, T1 hour, T2h, T3h, T4h, T7h, T8h.","definition_or_measurement_approach":"Measurement of plasma concentrations of methylphenidate (MPH) and its active metabolite (alpha-phenyl 2-piperidine acid) at specified time points up to 8 hours post-dose; primary outcome is the total area under the concentration–time curve (AUC) comparing obese versus non-obese patients."}

Secondary endpoints

• {"endpoint_text":"- Plasma concentrations of MPH and APP measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration.","definition_or_measurement_approach":"Serial plasma sampling at listed time points to quantify MPH and alpha-phenyl 2-piperidine acid (APP) concentrations up to 8 hours post-dose."}
• {"endpoint_text":"- Perceived effectiveness of MPH on attentional symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3).","definition_or_measurement_approach":"Patient self-assessment using a visual analog scale (score 1–7) at each pharmacokinetic sampling time point."}
• {"endpoint_text":"- Perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3).","definition_or_measurement_approach":"Patient self-assessment using a visual analog scale (score 1–7) at each pharmacokinetic sampling time point."}
• {"endpoint_text":"- Correlation between MPH concentrations and perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times.","definition_or_measurement_approach":"Statistical correlation analyses between measured plasma MPH/APP concentrations and VAS scores for hyperactivity/impulsivity across time points."}
• {"endpoint_text":"- Correlation between MPH concentrations and perceived effectiveness of MPH on inattention symptoms at these different times.","definition_or_measurement_approach":"Statistical correlation analyses between measured plasma MPH/APP concentrations and VAS scores for inattention across time points."}
• {"endpoint_text":"- Sociodemographic, medical and biological data (dates and times of sampling) for pharmacokinetic modeling: age, sex, weight, height (for BMI calculation), tobacco and alcohol consumption, morning breakfast intake, creatinine levels for eDFG calculation (CKD-EDI), blood count, complete liver work-up, initial severity of ADHD symptoms (Adult ADHD Self-Report Scale = ASRS-18, (Kessler et al. 2007)).","definition_or_measurement_approach":"Collection of baseline demographic, clinical and laboratory variables and timing data to support pharmacokinetic modelling and AUC calculations."}
• {"endpoint_text":"- Other individual psychological characteristics (baseline; Appendix 2): emotional dysregulation (total score on the Difficulties in Emotion Regulation Scale-36 items, Gratz & Roemer, 2004; French version: Dan-Glauser & Scherer, 2013), impulsivity (scores on each of the 5 dimensions of the UPPS-P French version: Billieux et al. 2012), bulimic hyperphagia (total score on the Binge Eating Scale, French version: Brunault et al. 2016).","definition_or_measurement_approach":"Baseline psychometric assessments using validated scales (DERS-36, UPPS-P, Binge Eating Scale) to explore associations with pharmacokinetics and perceived efficacy."}

Methods

• Patients pre-selected by psychiatrists at the Addictology Hospital Department of the CHRU de Tours during outpatient follow-up consultations; psychiatrists assess eligibility (absence of contraindication to MPH, BMI measurement, absence of non-inclusion criteria) and provide full information about the study. A cooling-off period of at least 24 hours and a maximum of 60 days occurs between selection and inclusion. All study procedures performed at CIC 1415 of the CHRU de Tours.

France

Earliest CTIS Part Ii Submission Date

28-02-2025

Latest Decision Or Authorization Date

28-04-2025

Processing Time Days

59

Number Of Sites

2

Number Of Participants

30

Primary sponsor

Full Name

Centre Hospitalier Regional Universitaire De Tours

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France