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

Epilepsy Clinical Trial

Official title:

Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482026
• Other study ID #: 2011.682/25
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: January 20, 2016
• Start date: November 2011
• Est. completion date: December 2015

Study information

• Verified date: January 2016
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: The Commission nationale de l’informatique et des libertés
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 173
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 16 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Epilepsy

Intervention

Other:
• ADHD Rating Scale-IV
ADHD Rating Scale-IV test
• ADHD Rating Scale-IV
ADHD Rating Scale-IV test

Locations

Country	Name	City	State
France	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 Neckert-Enfants malades	Paris
France	Service de Neurologie Pédiatrique, Hôpital Robert-Debré	Paris
France	Service de Pédiatrie, Hôpital Sud	Rennes
France	Centre Référent des Epilepsies Rares, Hôpital de Hautepierre	Strasbourg
France	Service de Neurologie Pédiatrique, Hôpital des Enfants	Toulouse
France	Service de Neurologie Pédiatrique, CHU de Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evolution of the ADHD rating scale IV global score	Evolution of the ADHD rating scale IV global score in treated versus non treated patients, after 12 to 16 weeks.	Change from baseline in ADHD rating scale IV global score at 12 to16 weeks	No
Secondary	Evolution of the ADHD rating scale IV hyperactivity subscore	Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.	Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks	No