Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Ongoing, recruiting
Participants planned
30
Countries
1
Sites
2
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, academic and/or occupational impact (American Psychiatric Association 2013). This disorder, whose prevalence is around 5% in children and adolescents, affects 2.6% of adults (American Psychiatric Association 2013; Song et al. 2021).
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.
Key facts
- Sponsor
- Centre Hospitalier Regional Universitaire De Tours
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Psychiatry and Psychology [F] - Mental Disorders [F03], Diseases [C] - Nervous System Diseases [C10], Psychiatry and Psychology [F] - Psychological Phenomena [F02]
- Trial duration
- 30 Mar 2026 → ongoing
- Decision date (initial)
- 2025-04-28
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Pharmacokinetic
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.
Secondary objectives 7
- Compare plasma concentrations at different times (immediately before MPH administration, i.e. T0, then T30 minutes, T1 hour, T2h, T3h, T4h, T6h, T8h after MPH administration) of MPH and APP, its active metabolite, between patients with ADHD and obesity and patients with ADHD but without obesity.
- Compare the perceived efficacy of MPH on attentional symptoms between patients with versus without obesity (at equivalent dosage and/or equivalent area under the curve).
- Compare the perceived efficacy of MPH on hyperactivity/impulsivity symptoms between patients with versus without obesity (at equivalent dosage).
- To study the correlation between plasma concentrations of MPH and its active metabolite on the one hand, and perceived efficacy on ADHD symptoms on the other, also comparing these correlations between people with and without obesity.
- To study the correlation between plasma concentrations of MPH and its active metabolite on the one hand, and perceived efficacy on hyperactivity/impulsivity-type ADHD symptoms on the other, also comparing these correlations between people with and without obesity.
- Test the reliability and validity of the pharmacokinetic model set up specifically for the study.
- To determine whether, at comparable dosage, certain individual psychological characteristics (impulsivity, emotional dysregulation, binge eating) are associated with greater efficacy of MPH on ADHD symptoms.
Conditions and MedDRA coding
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, academic and/or occupational impact (American Psychiatric Association 2013). This disorder, whose prevalence is around 5% in children and adolescents, affects 2.6% of adults (American Psychiatric Association 2013; Song et al. 2021).
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | LLT | 10068451 | ADHD combined type | 10037175 |
Study design 3 periods
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Selecting and recruiting research participants Patients will be pre-selected at the Addictology Hospital Department of the CHRU de Tours by the psychiatrists who see patients in outpatient follow-up consultations for ADHD. They will assess patients' eligibility in the context of ADHD (absence of contraindication to MPH, BMI measurement, absence of non-inclusion criteria). Psychiatrists will provide patients with full information about the study, its risks and constraints. Between patient selection and inclusion, there will be a cooling-off period of at least 24 hours and a maximum of 60 days.
Translated with DeepL.com (free version)
|
Not Applicable | None | ||
| 2 | Inclusion After completing any information and answering any questions the patient may still have
about the study, the investigator must obtain the patient's consent to participate.
participation. This document must be dated and signed by both the patient and the investigator during this visit, before any study-specific evaluation can take place. Patients who have signed a consent form and meet the inclusion criteria can be included in the study.
All procedures related to the study will be carried out at the CIC 1415 of the CHRU of Tours.
Patient demographics and medical history are collected.
Individual psychological characteristics will be assessed prior to administration by self-questionnaire (emotional dysregulation: DERS-36, impulsivity: UPPS-P, bulimic hyperphagia: BES; see Appendix 2).
Inclusion will take place from Monday to Thursday, due to sampling and transport constraints at the CRB-T (see below).
|
Not Applicable | None | ||
| 3 | Intervention, follow-up and care of the participant at the end of research All procedures related to the study will be performed at CIC 1415 of the CHRU de Tours.
Clinical and biological assessments, prior to MPH administration, will include: blood pressure, assessment of ADHD symptom intensity at inclusion (ASRS-18), associated symptoms (UPPS-P, DERS-36), FPN, creatininemia, complete liver work-up.
MPH administration: the usual dose of MPH (Ritalin ® LP) is administered in the early morning.
Repeated blood sampling for determination of plasma MPH and APP concentrations before administration (T0), then T30min (±10 min), T1h ±10 min, T2h ±30 min, T3h±30 min, T4h±30 min, T6h±30 min and T8h after administration.
The CIC IDE in charge of sampling will make a precise note of the exact times of sampling on the accompanying sample sheets, even if they differ from the theoretical time, in order to limit bias. Samples will be taken in trace-element sodium heparinate tubes, without separating gel (royal blue cap with black collar).
These samples will be sent and stored at the Centre de Ressources Biologiques de Touraine (CRB-T) the following day, once the tubes have been centrifuged and stored at -20°C at CIC 1415. In addition, 2 aliquots must be made and stored by the CRB-T. For each sample, one of the aliquots must be sent to the medical pharmacology department, and the second kept for security purposes.
Note: for pharmacokinetic analysis, 6 mL of blood will be collected in sodium heparin tubes at each of the 8 sampling times. A total of 48 mL of blood will therefore be collected per patient on each day of participation. Ultimately, these samples will be destroyed once the results have been analyzed.
Assessment of treatment efficacy and safety: visual analogue scale allowing patient self-assessment of ADHD symptoms at the same time as the samples are taken.
Patient discharged home, in the absence of serious adverse effects, with continuation of usual follow-up by the addictology department.
Pharmacokinetic analysis and modelling (Medical Pharmacology Department): after transfer from CRB-T at the end of the study, analysis of plasma samples for MPH and APP, followed by pharmacokinetic modelling based on patient data.
|
Not Applicable | None |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- 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
Exclusion criteria 11
- Contraindications to methylphenidate treatment (see pharmacological aspects below)
- 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)
- Patients under legal protection
- Patient's inability to self-assess the intensity of ADHD symptoms
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- 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 endpoints 7
- 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).
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
RITALINE L.P. 10 mg, gélule à libération prolongée
PRD9661976 · Product
- Active substance
- Methylphenidate Hydrochloride
- Pharmaceutical form
- PROLONGED-RELEASE CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 80 mg milligram(s)
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- N06BA04 — METHYLPHENIDATE
- Marketing authorisation
- 34009 416 867 6 4
- MA holder
- INFECTOPHARM ARZNEIMITTEL UND CONSILIUM GMBH
- MA country
- France
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Centre Hospitalier Regional Universitaire De Tours
- Sponsor organisation
- Centre Hospitalier Regional Universitaire De Tours
- Address
- 2 Boulevard Tonnelle
- City
- Tours
- Postcode
- 37000
- Country
- France
Scientific contact point
- Organisation
- Centre Hospitalier Regional Universitaire De Tours
- Contact name
- Professor Paul BRUNAULT
Public contact point
- Organisation
- Centre Hospitalier Regional Universitaire De Tours
- Contact name
- Professor Paul BRUNAULT
Locations
1 EU/EEA country · 2 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| France | Ongoing, recruiting | 30 | 2 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| France | 2026-03-30 | 2026-03-30 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 5 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol redacted_2024-519461-22-00 | 1.3 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements | 1.1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF | 1.2 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC_Ritaline LP | 1.1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_FR 2024-519461-22-00 | 1.4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-12-19 | France | Acceptable 2025-04-22
|
2025-04-28 |