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PHArmacoKinetics of methYLphenidate in adult patients with ADHD: comparison between patients with and without OBesity_PHACYLOB.

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-519461-22-00
Acronym
DR240305
Enrollment
30
Registered
2025-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

academic and/or occupational impact (American Psychiatric Association 2013). This disorder, affects 2.6% of adults (American Psychiatric Association 2013; Song et al. 2021)., Attention Deficit Disorder with or without Hyperactivity (ADHD) is a neurodevelopmental disorder characterized by disabling symptoms of inattention and/or hyperactivity-impulsivity beginning before the age of 12 with significant personal, social, whose prevalence is around 5% in children and adolescents

Brief summary

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.

Detailed description

Plasma concentrations of MPH and APP measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration., Perceived effectiveness of MPH on attentional symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3)., Perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3)., Correlation between MPH concentrations and perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times., Correlation between MPH concentrations and perceived effectiveness of MPH on inattention symptoms at these different times., 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))., 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).

Interventions

DRUGRITALINE L.P. 10 mg
DRUGgélule à libération prolongée

Sponsors

Centre Hospitalier Regional Universitaire De Tours
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Plasma concentrations of MPH and APP measured up to 8 hours (T0, T30 minutes, T1h, T2h, T3h, T4h, T6h, T8h) after MPH administration., Perceived effectiveness of MPH on attentional symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3)., Perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times (visual analog scale, score from 1 to 7; Appendix 3)., Correlation between MPH concentrations and perceived effectiveness of MPH on hyperactivity/impulsivity symptoms at these different times., Correlation between MPH concentrations and perceived effectiveness of MPH on inattention symptoms at these different times., 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

Countries

France

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026