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ADHD-addMETANCT06906328

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

A study testing Cognitive remediation program, with the PRESCO® software in people with ADHD-add, run by Nantes University Hospital at 6 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

MEthylphenidate in ADHD - Addiction(s) comorbidity: benefit of adding a cognitive remediation program to improve short- and medium-term therapeutic response Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
ADHD-add
What is being tested?
Cognitive remediation program, with the PRESCO® software
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
6 sitesFrance
Study dates
11 Dec 2025to 11 Dec 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age over 18;
  • Diagnosis of ADHD confirmed by DIVA-5 interview 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 (SUD and/or BA);
  • Having given their consent to take part in the study;
  • Being affiliated to the French social security system or benefiting from such a system.

Who cannot join

  • 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.
  • Patients who consumned psychoactive substances within 12 hours prior to their visit.

Trial locations and contacts

6 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Clémence Dr Cabelguen, MD-Phd contact

33240846116

clemence.cabelguen@chu-nantes.fr

6 sites in 1 country

France6 sites, 6 recruiting
  • CH Georges Daumézon - Bouguenais

    Bouguenais, Loire-Atlantique, 44342

    Jennyfer Dr CHOLET, MD-PhD, 33251829300, jennyfer.Cholet@ch-gdaumezon.fr

    Not yet recruiting
  • CHRU Brest

    Brest, Brittany Region, 29609

    Morgane Dr GUILLOU-LANDREAT, MD-PhD, 33298342348, morgane.guillou@chu-brest.fr

    Not yet recruiting
  • EPSM Georges Daumézon (Fleury-les-Aubrais, Loiret)

    Fleury-les-Aubrais, Centre-Val de Loire, 45400

    Raphaël Dr SERREAU, MD-Phd, 33251829319, raphael.serreau@epsm-loiret.fr

    Not yet recruiting
  • CHU Nantes

    Nantes

    Clémence CABELGUEN, 02 40 84 61 16, clemence.cabelguen@chu-nantes.fr

    Recruiting
  • EPSM du Finistère Sud

    Quimper, Brittany Region, 29000

    Stéphane Dr BILLARD, MD-PhD, 33298986600, sbillard@epsm-quimper.fr

    Not yet recruiting
  • CHRU de Tours

    Tours, Centre-Val de Loire, 37000

    Paul Dr BRUNAULT, MD-PhD, 33234379631, paul.brunault@univ-tours.fr

    Not yet recruiting

Other trials in France

About this study

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

Read the 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
Being tested
Cognitive remediation program, with the PRESCO® software, Control program, with the AUDITICO® software
Keywords
Methylphenidate, Cognitive remediation, Functional improvement

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive remediation program, with the PRESCO® softwareBehavioural

    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).

  • Control program, with the AUDITICO® softwareBehavioural

    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.

Study groups in NCT06906328
Study groupRoleWhat they receive
Cognitive remediation programExperimentalThe cognitive remediation program under study (experimental treatment) consists of cognitive exercises performed on computers, in 30-45 minute sessions. The cognitive exercises target the deficits commonly observed in ADHD, a fortiori when it is associated with addictive disorders (working memory, inhibitory control, cognitive flexibility, attention, planning). 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).
Receives: Behavioral: Cognitive remediation program, with the PRESCO® software
Control programActive comparatorFor 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.
Receives: Behavioral: Control program, with the AUDITICO® software

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program

    Evaluate the effectiveness of cognitive remediation versus the control program, alongside MPH treatment, in reducing the functional impact of ADHD in patients with addictive comorbidities at the end of treatment

    Functional improvement can be defined as an improvement of at least 30% in the functional impact score between post- and pre-treatment assessment. In our study, the functional outcome score used will be the global score of the WFIRS (Weiss Functional Impairment Rating Scale, A score of more than 1.5 points is considered to be representative of an impairment in the area concerned. Higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 3 respectively) questionnaire. The primary endpoint will therefore be the proportion of patients achieving functional improvement (at least 30% improvement in WFIRS score) in each group, estimated at the end of treatment.

    Measured: 9 month

Secondary outcomes (7)
  1. Sustained ADHD functional improvement, 6 months after the end of CRT.

    To evaluate the efficacy 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, 6 months after the end of treatment

    The endpoint will be the proportion of patients achieving functional improvement (at least 30% improvement in WFIRS score (Weiss Functional Impairment Rating Scale, A score of more than 1.5 points is considered to be representative of an impairment in the area concerned. Higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 3 respectively)) in each group, estimated 6 months after the end of treatment.

    Measured: 9 month

  2. Immediate and sustained ADHD symptom improvement, both at the end of CRT and 6 months later.

    To evaluate the efficacy of cognitive remediation versus the control program, alongside MPH treatment, in reducing ADHD symptoms in patients with comorbid addictions, at the end of treatment and 6 months post-treatment

    The evaluation criterion will be the proportion of patients who achieved symptom improvement (at least 30% improvement in the ASRS score (Adult ADHD Self-Report Scale Symptom Checklist, higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 36 respectively) for the dominant ADHD subtype, or either in case of combined type) in each group, estimated at treatment end or 6 months later.

    Measured: 9 month

  3. Immediate and sustained improvement of neuropsychological deficits, both at the end of CRT and 6 months later.

    To compare the efficacy of cognitive remediation versus the control program in addition to MPH treatment, at the end of treatment and 6 months after the end of treatment, in improving neuropsychological deficits.

    Neuropsychological deficits will be evaluated using performance scores on a series of neurocognitive tasks assessing key cognitive functions (all performance scores will be standardized to be comparable, i.e. Z-scores):

    • D2-R (selective attention),
    • Digit memory test (short-term memory and working memory),
    • Stroop test (inhibition),
    • Verbal fluency test (spontaneous flexibility)
    • Zoo test (planning)

    Measured: 9 month

  4. Immediate and sustained improvement of the severity of comorbid addictive disorders, both at the end of CRT and 6 months later.

    To compare the efficacy of cognitive remediation versus the control program in addition to MPH treatment, at the end of treatment and 6 months after the end of treatment, in reducing the severity of comorbid addictive disorders

    The severity of comorbid addictive disorders will be assessed based on the number of diagnostic criteria met in the diagnostic interviews, including:

    • MINI-S (alcohol and substance use disorders),
    • NODS (gambling disorder),
    • Diagnostic interview adapted from NODS for sexual addiction,
    • Diagnostic interview adapted from NODS for gaming disorder,
    • YFAS for food addiction,
    • Mc Elroy for compulsive buying.

    Measured: 9 month

  5. Immediate and sustained improvement of the psychopathological characteristics associated with ADHD-addiction(s) comorbidity, both at the end of CRT and 6 months later.

    Compare the efficacy of cognitive remediation versus the control program, in addition to MPH treatment, at the end of treatment and 6 months later, in alleviating psychopathological features associated with ADHD-addiction(s) comorbidity. Psychopathological characteristics associated with ADHD-addiction(s) comorbidity will be assessed by (all scores will be standardized to be comparable, i.e. Z-scores):

    • UPPS-P (Urgency, Premeditation (lack of), Perseverance (lack of), Sensation seeking impulsivity behavior scale, higher scores mean a worse outcome, the minimum and maximum values for each score are 4 and 16 respectively), (impulsivity): 5 scores,
    • DERS-16(Difficulties in Emotion Regulation Scale, higher scores mean a worse outcome, the minimum and maximum values are 16 and 80 respectively), (emotional dysregulation): 5 scores,
    • RSES (Rosenberg Self-Esteem Scale, higher score mean a better outcome, the minimum and maximum values are 10 and 40 respectively), (self-esteem): 1 score.

    Measured: 9 month

  6. Immediate and sustained improvement of adherence to MPH treatment, both at the end of CRT and 6 months later.

    To compare the efficacy of cognitive remediation versus the control program in addition to MPH treatment, at the end of treatment and 6 months after the end of treatment, in enhancing adherence to MPH treatment through CRT.

    Adherence to treatment will be evaluated based on:

    • Compliance with and tolerance to medication (structured interview, vital signs, and weight checks at follow-up visits)
    • The number of CRT sessions completed relative to the number of planned sessions.

    Measured: 9 month

  7. 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)

    To analyze the short- and medium-term evolution of functional impairment based on ADHD subtype (predominantly inattentive, predominantly impulsive/hyperactive, or combined type).

    Functional impairment will be assessed using the WFIRS (Weiss Functional Impairment Rating Scale, A score of more than 1.5 points is considered to be representative of an impairment in the area concerned. Higher scores mean a worse outcome, the minimum and maximum values for each score are 0 and 3 respectively), (improvement of at least 30% in the functional impact score between post- and pre-treatment assessment), and the ADHD subtype will be determined using the DIVA-5 diagnostic interview.

    Measured: 9 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Apr 2025
  2. Study start11 Dec 2025
  3. Primary completion11 Dec 2028 (estimated)
  4. Study completion11 Dec 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
248 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06906328
Sponsor's protocol ID
RC23_0506
Acronym
META
Status last verified
Feb 2026
First submitted
23 Jan 2025
Last updated
19 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Cabelguen C, Challet-Bouju G, Thiabaud E, Donnio Y, Lefebvre L, Hardouin JB, Grall-Bronnec M. Randomised controlled trial on the efficacy of adding cognitive remediation therapy to methylphenidate in adult patients with attention deficit hyperactivity disorder and addictive disorders (META): CRT in ADHD and addiction - META study protocol. BMJ Open. 2026 Mar 31;16(3):e111698. doi: 10.1136/bmjopen-2025-111698.

    PubMed 41916643

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive remediation program, with the PRESCO® software in people with ADHD-add, run by Nantes University Hospital at 6 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clémence Dr Cabelguen, MD-Phd (33240846116, clemence.cabelguen@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program (time frame: 9 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06906328, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2026.

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