Attention Deficit Hyperactivity Disorder

Attention Deficit Hyperactivity Disorder Clinical Trial

— ADA  

Official title:

Addictions and Attention Deficit Disorder With or Without Hyperactivity

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06232226
• Other study ID #: RC23_0074
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: March 1, 2026

Study information

• Verified date: April 2024
• Source: Nantes University Hospital
• Contact: Clémence CABELGUEN, PH
• Phone: 33 2 40 84 61 16
• Email: clemence.cabelguen[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The ADA cohort aims for the systematic and standardized collection of sociodemographic, clinical and neuropsychological data, during 2 visits (inclusion and 12 months), from patients suffering from the co-occurrence of ADHD (Attention Deficit Hyperactivity Disorder) and addiction(s), in addition to the treatment as usual adapted to each situation.

Description:

Information on the study and diagnosis of ADHD will be carried out during a medical evaluation consultation, as part of routine care. The two research visits (inclusion and at 12 months) will be added by the research and will each include: - A structured clinical interview with a research professional (traceability of oral consent, administration of structured interviews, collection of self-questionnaires, collection of care from the medical record) - A neuropsychological assessment with a neuropsychologist

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 99 Years

Eligibility

Inclusion Criteria :

• Patients aged over 15 years and 3 months
• For whom a diagnosis of ADHD has been confirmed less than 6 weeks ago
• For whom the diagnosis of one or more addictive disorder(s) (substance use disorder or behavioral addiction) has been confirmed
• Meeting the indication for treatment with MPH according to European recommendations (Kooij et al., 2019)
• For patients who can actually benefit from MPH: who have not yet started taking MPH
• Social security affiliates

Exclusion Criteria :

• Presenting disorders of higher cognitive functions (at the discretion of the referring clinician or the investigator making the inclusion), making data collection impossible
• Presenting difficulties in reading or writing the French language making data collection impossible
• Unable to commit to being available for the 2 visits planned as part of the cohort
• Under guardianship or legal protection

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Behavior Disorders
• Hyperkinesis
• Mental Disorders

Intervention

Other:
• Patients suffering from the co-occurrence of ADHD and addiction(s)
All eligible patients over 15 years and 3 months (age limit between child psychiatry and adult psychiatry), presenting both a diagnosis of ADHD and a diagnosis of at least one addictive disorder (SUD, AUD (Alcohol Use Disorder) and/ or behavioral addiction), starting care in one of the three participating centers, and meeting the indication for treatment with MPH according to European recommendations (J. J. S. Kooij et al., 2019)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional impairment	Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)	Inclusion and 12-month follow-up
Secondary	Type and severity of ADHD	Diagnostiscal Interview Voor Attention deficit hyperactivity disorder (DIVA-5)	Inclusion
Secondary	Symptoms of ADHD	Adult ADHD Self-Report Scale Symptom Checklist (ASRS-1.1) (inattention and hyperactivity/impulsivity scores)	Inclusion and 12-month follow-up
Secondary	Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)	Mini International Neuropsychiatric Interview- Simplified for Diagnostic and Statistical Manual (DSM)-5 (MINI-S)	Inclusion and 12-month follow-up
Secondary	Addictive disorders - gambling disorder	National Opinion research center DSM Screen for gambling problems (NODS)	Inclusion and 12-month follow-up
Secondary	Addictive disorders - sex addiction	Structured interview adapted from the NODS to explore the diagnostic criteria proposed by Carnes et al in 2012	Inclusion and 12-month follow-up
Secondary	Addictive disorders - gambling disorder	Structured interview adapted from the NODS to explore the diagnostic criteria proposed in the third section of the DSM-5 for the Internet gaming disorder	Inclusion and 12-month follow-up
Secondary	Addictive disorders - eating addiction	Yale Food Addiction Scale (YFAS 2.0)	Inclusion and 12-month follow-up
Secondary	Psychiatric disorders	MINI-S	Inclusion and 12-month follow-up
Secondary	Neuropsychological profile - selective attention	D2-R test (CCT standard score, E% standard score and CC standard score)	Inclusion and 12-month follow-up
Secondary	Neuropsychological profile - short-term and working memory	Digit memory test (standardized scores of numbers of items correctly recalled (direct order, indirect order, ascending order, total), span sizes (direct order, indirect order, ascending order))	Inclusion and 12-month follow-up
Secondary	Neuropsychological profile - inhibition	Stroop test (standardized execution times (naming condition, interference condition), standardized numbers of uncorrected errors (naming condition, interference condition), and standardized interference score)	Inclusion and 12-month follow-up
Secondary	Neuropsychological profile - spontaneous flexibility	Verbal fluency test (standardized scores for the number of words cited and the number of errors, in both conditions (literal and categorical))	Inclusion and 12-month follow-up
Secondary	Neuropsychological profile - planning	Zoo test (total profile score)	Inclusion and 12-month follow-up
Secondary	Psychopathological profile - impulsivity	Urgency, Premeditation (lack of), Perseverance (lack of), Sensation seeking impulsivity behavior scale (UPPS-P) (5 scores)	Inclusion and 12-month follow-up
Secondary	Psychopathological profile - emotional dysregulation	Difficulties in Emotion Regulation Scale (DERS-16) (5 scores and total score)	Inclusion and 12-month follow-up
Secondary	Psychopathological profile - sensorial profile	Sensory profile of Winnie Dunn - adult version (category and raw scores in the 4 quadrants)	Inclusion and 12-month follow-up
Secondary	Psychopathological profile - self-esteem	Rosenberg Self-Esteem Scale (RSES) (total score)	Inclusion and 12-month follow-up
Secondary	Quality of life	World Health Organization Quality Of Life (WHOQoL-26) (4 scores)	Inclusion and 12-month follow-up
Secondary	Care received	Effective implementation of treatment with MPH (yes/no) or atomoxetine (yes/no), If no, reasons for not implementing it (for MPH), Care provided (Cognitive remediation / behavioral and cognitive therapy / psychoeducation / other psychosocial intervention (details) / other drug treatment), Reported compliance and misuse for MPH and atomoxetine, Reported compliance for non-drug care, Tolerance: numerical scale from 0 to 10 for the evaluation of the main adverse effects (for MPH and for atomoxetine).	12-month follow-up
Secondary	Personal and family medical history	List of somatic, psychiatric and addictive disorders for personal history, list of psychiatric and addictive disorders for family history	Inclusion
Secondary	Sociodemographics	Age, gender, level of education, professional status, number of children	Inclusion