NCT06906328

MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Nantes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

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.

Conditions

• ADHD-add

Interventions

Type	Name	Description
BEHAVIORAL	Cognitive remediation program, with the PRESCO® software	The program runs for 16 weeks, with two sessions per week, one with a neuropsychologist. In the first 4 weeks, the patient will have weekly sessions at the center and complete the other session at home using the app provided for the study. For the next 8 weeks, sessions with the neuropsychologist will be every other week, with the other session at home. The neuropsychologist will track progress through the software history and follow up by phone if needed. The proposed program will be based on a software solution for cognitive rehabilitation, developed and validated for the treatment of attention and memory disorders and neurodegenerative, neurotraumatic and neuropsychiatric pathologies (PRESCO® software, marketed by HappyNeuron).
BEHAVIORAL	Control program, with the AUDITICO® software	Control program, with the same functional characteristics but without the targeted cognitive functions. For the control program (comparator), we will use a software solution from the same company, but dedicated to stimulating and training auditory functions (AUDITICO® software). The advantage of this solution is that, like PRESCO®, it offers training exercises that are not aimed at re-educating cognitive functions. These include, for example, sound identification and discrimination activities. This tool can also be used by anyone, and is accessible for follow-up by the practitioner. It also offers levels of increasing difficulty, making it stimulating for users.

Timeline

• Start date: 2025-12-11
• Primary completion: 2028-12-11
• Completion: 2029-12-11
• First posted: 2025-04-02
• Last updated: 2026-02-19

Locations

6 sites across 1 country: France