Clinical trial NCT01482026: Attention-Deficit Hyperactivity Disorder (ADHD) Rating Scale and Epilepsy
Official title: Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Attention deficit
ADHD rating scale IV
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2011-11-30
Enrollment: 173
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Evolution of the ADHD rating scale IV inattention subscore
timeFrame: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks
Secondary outcomes:
measure: Evolution of the ADHD rating scale IV global score
timeFrame: Change from baseline in ADHD rating scale IV global score at 12 to16 weeks
measure: Evolution of the ADHD rating scale IV hyperactivity subscore
timeFrame: Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks
Other outcomes:
Locations:
city: Amiens
country: France
facility: Service de Neurologie pédiatrique, CHU d'Amiens
city: Angers
country: France
facility: Service de Neurologie Pédiatrique, CHU d'Angers
city: Besançon
country: France
facility: Service de Neurologie pédiatrique, CHU de Besançon
city: Bordeaux
country: France
facility: Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin
city: Bron
country: France
facility: Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant
city: Bron
country: France
facility: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer
city: Chambéry
country: France
facility: Service d'épileptologie pédiatrique, CHR de Chambéry
city: Lyon
country: France
facility: Cabinet Médical du Dr ISNARD
city: Marseille
country: France
facility: Service de Neurologie pédiatrique, Hôpital de la Timone
city: Paris
country: France
facility: Service de Neurologie Pédiatrique, Hôpital Robert-Debré
city: Paris
country: France
facility: Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades
city: Rennes
country: France
facility: Service de Pédiatrie, Hôpital Sud
city: Strasbourg
country: France
facility: Centre Référent des Epilepsies Rares, Hôpital de Hautepierre
city: Toulouse
country: France
facility: Service de Neurologie Pédiatrique, Hôpital des Enfants
city: Tours
country: France
facility: Service de Neurologie Pédiatrique, CHU de Tours
Study officials:
affiliation: Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
name: Sylvain RHEIMS, MD
role: PRINCIPAL_INVESTIGATOR
References: