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

Not Applicable

Completed

• Conditions: Epilepsy

• Registration Number: NCT01482026
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-24
• Study First Submitted QC: 2011-11-29
• Study First Posted: 2011-11-30
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 173

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Evolution of the ADHD rating scale IV inattention subscore	Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks	Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.

Secondary Outcome Measures

Name	Time	Method
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 global score in treated versus non treated patients, after 12 to 16 weeks.
Evolution of the ADHD rating scale IV hyperactivity subscore	Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks	Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.

Trial Locations

Locations (15)

Service de Neurologie pédiatrique, CHU d'Amiens; 🇫🇷 Amiens, France

Service de Neurologie Pédiatrique, CHU d'Angers; 🇫🇷 Angers, France

Service de Neurologie pédiatrique, CHU de Besançon; 🇫🇷 Besançon, France

Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin; 🇫🇷 Bordeaux, France

Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant; 🇫🇷 Bron, France

Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer; 🇫🇷 Bron, France

Service d'épileptologie pédiatrique, CHR de Chambéry; 🇫🇷 Chambéry, France

Cabinet Médical du Dr ISNARD; 🇫🇷 Lyon, France

Service de Neurologie pédiatrique, Hôpital de la Timone; 🇫🇷 Marseille, France

Service de Neurologie Pédiatrique, Hôpital Robert-Debré; 🇫🇷 Paris, France

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