NCT06232226

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Apr 2024

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress76%
Apr 2024Dec 2026

First Submitted

Initial submission to the registry

January 22, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 11, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

2.7 years

First QC Date

January 22, 2024

Last Update Submit

April 14, 2026

Conditions

Attention Deficit Hyperactivity DisorderBehavior HyperactiveBehavior Disorders

Keywords

Attention Deficit Disorder with HyperactivityAddictive disordersNeuropsychologyMethylphenidateAtomoxetineFunctional impairmentSymptoms

Outcome Measures

Primary Outcomes (1)

  • Functional impairment

    Weiss Functional Impairment Rating Scale (WFIRS-S) (scores of the 7 domains and total score)

    Inclusion and 12-month follow-up

Secondary Outcomes (21)

  • Type and severity of ADHD

    Inclusion

  • Symptoms of ADHD

    Inclusion and 12-month follow-up

  • Addictive disorders - substance use disorders (including tobacco, alcohol and other substances)

    Inclusion and 12-month follow-up

  • Addictive disorders - gambling disorder

    Inclusion and 12-month follow-up

  • Addictive disorders - sex addiction

    Inclusion and 12-month follow-up

  • +16 more secondary outcomes

Study Arms (1)

Neuropsychological assessment

OTHER

Determination of the neuropsychological profile

Other: Patients suffering from the co-occurrence of ADHD and addiction(s)

Interventions

Patients suffering from the co-occurrence of ADHD and addiction(s)OTHER

All eligible patients over 18 years, 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)

Neuropsychological assessment

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged over 18 years
  • For whom a diagnosis of ADHD has been confirmed less than 12 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

You may not qualify if:

  • 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
  • Patients who have used psychoactive substances within 12 hours prior to their visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

CHRU de Brest

Brest, 29000, France

RECRUITING

CHRU de Tours

Tours, 37000, France

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivitySpasmMental Disorders

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Clémence CABELGUEN, PH

CONTACT

33 2 40 84 61 16clemence.cabelguen@chu-nantes.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Cohort
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2024

First Posted

January 30, 2024

Study Start

April 11, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(3)