Clinical trial NCT06906328: MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response
Official title: MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: ADHD-add
Keywords: Methylphenidate
Cognitive remediation
Functional improvement
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 248
Sex: ALL
Minimum age (years): 15
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: MEthylphenidate in ADHD - Addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response

Detailed description: It seems essential to optimize the therapeutic management of patients suffering from ADHD/addiction(s) comorbidity by specifically targeting their neuropsychological deficits, in addition to the pharmacological and psychosocial approaches currently recommended. By intensively training deficient functions on the one hand, and promoting the development of compensatory strategies on the other, cognitive remediation could thus be a therapeutic tool of choice, producing beneficial effects that persist over time and translate into objectifiable changes in daily life. Cognitive training programs have been successfully proposed to patients with ADHD, but these were mainly programs designed for children, and very few studies have been carried out in adults, a fortiori in adults with ADHD-addiction(s) comorbidity.

The main aim of the study was to evaluate the effectiveness of cognitive remediation compared with the control program in addition to MPH treatment in reducing the functional impact of ADHD in patients with other addictive comorbidities, at the end of treatment.

Eligibility criteria: Inclusion Criteria:

* Age over 15 (patients treated in the "adult" stream);
* Diagnosis of ADHD confirmed by DIVA-5 interview (for patients over 18) or Young DIVA-5 (for patients between 15 and 17) following a specialized ADHD-addiction(s) consultation;
* Indication for MPH treatment according to European recommendations (J. J. S. Kooij et al., 2019) and absence of contraindications (particularly cardiological);
* Presence of at least one comorbid addictive disorder (TUS and/or AC);
* Having given their consent to take part in the study;
* Being affiliated to the French social security system or benefiting from such a system.

Exclusion Criteria:

* Presence of disorders of the higher functions or difficulties in reading or writing the French language making it impossible to collect data;
* Pregnant or breast-feeding woman;
* Person deprived of liberty;
* Person under compulsory psychiatric care;
* Participation in another interventional research protocol involving another psychotherapeutic or pharmacological intervention that may have an impact on clinical outcome;
* Guardianship or safeguard of justice.

Primary outcomes:
measure: Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program
timeFrame: 9 month
Secondary outcomes:
measure: Sustained ADHD functional improvement, 6 months after the end of CRT.
timeFrame: 9 month
measure: Immediate and sustained ADHD symptom improvement, both at the end of CRT and 6 months later.
timeFrame: 9 month
measure: Immediate and sustained improvement of neuropsychological deficits, both at the end of CRT and 6 months later.
timeFrame: 9 month
measure: Immediate and sustained improvement of the severity of comorbid addictive disorders, both at the end of CRT and 6 months later.
timeFrame: 9 month
measure: Immediate and sustained improvement of the psychopathological characteristics associated with ADHD-addiction(s) comorbidity, both at the end of CRT and 6 months later.
timeFrame: 9 month
measure: Immediate and sustained improvement of adherence to MPH treatment, both at the end of CRT and 6 months later.
timeFrame: 9 month
measure: Immediate and sustained ADHD functional improvement, both at the end of CRT and 6 months later, compared between ADHD subtypes (predominantly inattentive, predominantly impulsive/hyperactive, or combined type)
timeFrame: 9 month
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
state: Bretagne
city: Quimper
country: France
facility: EPSM du Finistère Sud
state: Bretagne
city: Fleury-les-Aubrais
country: France
facility: EPSM Georges Daumézon (Fleury-les-Aubrais, Loiret)
state: Centre-Val De Loire
city: Tours
country: France
facility: CHRU de Tours
state: Centre-Val De Loire
city: Bouguenais
country: France
facility: CH Georges Daumézon - Bouguenais
state: Loire-Atlantique
Study officials:
References: