Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy
Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study
1 other identifier
interventional
173
1 country
15
Brief Summary
The cognitive and psychiatric comorbidities are crucial endpoints in epileptic patients. Among these comorbidities, the Attention-Deficit Hyperactivity Disorder (ADHD) accounts for one of the most important in terms of frequency and psychosocial and educational consequences. In these conditions, our study was designed to estimate the sensitivity to changes of the different sub-scores of the ADHD rating Scale IV (ADHD RS IV) in epileptic patient. This will then optimize our methodological approach for a therapeutic trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2011
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 24, 2011
CompletedFirst Posted
Study publicly available on registry
November 30, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2015
CompletedSeptember 9, 2025
January 1, 2016
4.1 years
November 24, 2011
September 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evolution of the ADHD rating scale IV inattention subscore
Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.
Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks
Secondary Outcomes (2)
Evolution of the ADHD rating scale IV global score
Change from baseline in ADHD rating scale IV global score at 12 to16 weeks
Evolution of the ADHD rating scale IV hyperactivity subscore
Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks
Study Arms (2)
Treated patients
EXPERIMENTALPatients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore
Non treated patients
EXPERIMENTALPatients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore
Interventions
Eligibility Criteria
You may qualify if:
- children aged 6 to 15 years and 11 months;
- male or female;
- with a diagnosis of ADHD : predominantly inattentive or combined hyperactive-impulsive and inattentive according to the DSM IV criteria;
- children who agreed to participate to the protocol and whose legal representatives have clearly expressed their non-opposition to participate.
You may not qualify if:
- Patients below 6 years old or patients older than 16 years;
- with a diagnosis of ADHD predominantly hyperactive-impulsive subtype ADHD according to the DSM IV criteria;
- mental retardation defined by a score \< 70 at the verbal comprehension index and the perceptual reasoning score of the Wechsler Intelligence Scale for Children - Fourth Edition (WISC-IV)
- established diagnosis of any psychiatric co-morbidity other than ADHD according to the DSM IV criteria (pervasive developmental disorders including autism, bipolar disorder, psychotic disorder).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Service de Neurologie pédiatrique, CHU d'Amiens
Amiens, 80054, France
Service de Neurologie Pédiatrique, CHU d'Angers
Angers, 49033, France
Service de Neurologie pédiatrique, CHU de Besançon
Besançon, 25030, France
Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin
Bordeaux, 33076, France
Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant
Bron, 69677, France
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer
Bron, 69677, France
Service d'épileptologie pédiatrique, CHR de Chambéry
Chambéry, 73011, France
Cabinet Médical du Dr ISNARD
Lyon, 69002, France
Service de Neurologie pédiatrique, Hôpital de la Timone
Marseille, 13385, France
Service de Neurologie Pédiatrique, Hôpital Robert-Debré
Paris, 75019, France
Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades
Paris, 75743, France
Service de Pédiatrie, Hôpital Sud
Rennes, 35203, France
Centre Référent des Epilepsies Rares, Hôpital de Hautepierre
Strasbourg, 67098, France
Service de Neurologie Pédiatrique, Hôpital des Enfants
Toulouse, 31059, France
Service de Neurologie Pédiatrique, CHU de Tours
Tours, 37044, France
Related Publications (1)
Mercier C, Roche S, Gaillard S, Kassai B, Arzimanoglou A, Herbillon V, Roy P, Rheims S. Partial validation of a French version of the ADHD-rating scale IV on a French population of children with ADHD and epilepsy. Factorial structure, reliability, and responsiveness. Epilepsy Behav. 2016 May;58:1-6. doi: 10.1016/j.yebeh.2016.02.016. Epub 2016 Mar 15.
PMID: 26991745RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sylvain RHEIMS, MD
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 24, 2011
First Posted
November 30, 2011
Study Start
November 1, 2011
Primary Completion
December 1, 2015
Study Completion
December 1, 2015
Last Updated
September 9, 2025
Record last verified: 2016-01