MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response
NCT06906328, Not applicable, Recruiting, Nantes University Hospital
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | MEthylphenidate in ADHD - Addiction(s) Comorbidity: Value of Adding a Cognitive Remediation Program to Improve Short- and Medium-term Therapeutic Response | ClinicalTrials.gov |
| NCT number | NCT06906328 | ClinicalTrials.gov |
| Status | Recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 248 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Nantes University Hospital | ClinicalTrials.gov |
| Conditions | ADHD-add | ClinicalTrials.gov |
| Interventions | Cognitive remediation program, with the PRESCO® software, Control program, with the AUDITICO® software | ClinicalTrials.gov |
| First posted | 2025-04-02 | ClinicalTrials.gov |
| Last updated | 2026-02-19 | ClinicalTrials.gov |
Registered outcomes 8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Immediate ADHD functional improvement, at the end of the CRT (Cognitive remediation therapy) program | 9 month | 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. | ClinicalTrials.gov |
| Secondary | Sustained ADHD functional improvement, 6 months after the end of CRT. | 9 month | 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. | ClinicalTrials.gov |
| Secondary | Immediate and sustained ADHD symptom improvement, both at the end of CRT and 6 months later. | 9 month | 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. | ClinicalTrials.gov |
| Secondary | Immediate and sustained improvement of neuropsychological deficits, both at the end of CRT and 6 months later. | 9 month | 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) | ClinicalTrials.gov |
| Secondary | Immediate and sustained improvement of the severity of comorbid addictive disorders, both at the end of CRT and 6 months later. | 9 month | 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. | ClinicalTrials.gov |
| Secondary | Immediate and sustained improvement of the psychopathological characteristics associated with ADHD-addiction(s) comorbidity, both at the end of CRT and 6 months later. | 9 month | 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. | ClinicalTrials.gov |
| Secondary | Immediate and sustained improvement of adherence to MPH treatment, both at the end of CRT and 6 months later. | 9 month | 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. | ClinicalTrials.gov |
| Secondary | 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) | 9 month | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|---|---|
| 41916643 | DERIVED | PubMed |
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 2
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Stroop Color-Word Test | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)