Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy

NCT ID: NCT01482026

Last Updated: 2025-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Epilepsy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Treated patients

Patients for whom ADHD treatment is introduced at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore

Group Type EXPERIMENTAL

ADHD Rating Scale-IV

Intervention Type OTHER

ADHD Rating Scale-IV test

Non treated patients

Patients for whom no ADHD treatment is required at enrolment. Evolution of the ADHD Rating Scale-IV inattention subscore

Group Type EXPERIMENTAL

ADHD Rating Scale-IV

Intervention Type OTHER

ADHD Rating Scale-IV test

Interventions

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ADHD Rating Scale-IV

ADHD Rating Scale-IV test

Intervention Type OTHER

ADHD Rating Scale-IV

ADHD Rating Scale-IV test

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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).
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sylvain RHEIMS, MD

Role: PRINCIPAL_INVESTIGATOR

Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon

Locations

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Service de Neurologie pédiatrique, CHU d'Amiens

Amiens, , France

Site Status

Service de Neurologie Pédiatrique, CHU d'Angers

Angers, , France

Site Status

Service de Neurologie pédiatrique, CHU de Besançon

Besançon, , France

Site Status

Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin

Bordeaux, , France

Site Status

Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant

Bron, , France

Site Status

Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer

Bron, , France

Site Status

Service d'épileptologie pédiatrique, CHR de Chambéry

Chambéry, , France

Site Status

Cabinet Médical du Dr ISNARD

Lyon, , France

Site Status

Service de Neurologie pédiatrique, Hôpital de la Timone

Marseille, , France

Site Status

Service de Neurologie Pédiatrique, Hôpital Robert-Debré

Paris, , France

Site Status

Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades

Paris, , France

Site Status

Service de Pédiatrie, Hôpital Sud

Rennes, , France

Site Status

Centre Référent des Epilepsies Rares, Hôpital de Hautepierre

Strasbourg, , France

Site Status

Service de Neurologie Pédiatrique, Hôpital des Enfants

Toulouse, , France

Site Status

Service de Neurologie Pédiatrique, CHU de Tours

Tours, , France

Site Status

Countries

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France

References

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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.

Reference Type RESULT
PMID: 26991745 (View on PubMed)

Other Identifiers

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2011.682/25

Identifier Type: -

Identifier Source: org_study_id

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