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

This study is currently recruiting participants.
Verified November 2011 by Hospices Civils de Lyon
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon
ClinicalTrials.gov Identifier:
NCT01482026
First received: November 24, 2011
Last updated: November 29, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Epilepsy
 Other: ADHD Rating Scale-IV

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Sensitivity of ADHD-IV Rating Scale in the Evaluation of the Evolution of Attention Disorders Associated With Childhood Epilepsy : a Validation Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospices Civils de Lyon:

Primary Outcome Measures:
  • Evolution of the ADHD rating scale IV inattention subscore [ Time Frame: Change from baseline in ADHD rating scale IV inattention subscore at 12 to16 weeks ] [ Designated as safety issue: No ]
    Evolution of the ADHD rating scale IV inattention subscore in treated versus non treated patients, after 12 to 16 weeks.


Secondary Outcome Measures:
  • Evolution of the ADHD rating scale IV global score [ Time Frame: Change from baseline in ADHD rating scale IV global score at 12 to16 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Change from baseline in ADHD rating scale IV hyperactivity subscore at 12 to16 weeks ] [ Designated as safety issue: No ]
    Evolution of the ADHD rating scale IV hyperactivity subscore in treated versus non treated patients, after 12 to 16 weeks.


Estimated Enrollment: 252
Study Start Date: November 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treated patients
Patients for whom ADHD treatment is introduced at enrolment
 Other: ADHD Rating Scale-IV
ADHD Rating Scale-IV test
Experimental: Non treated patients
Patients for whom no ADHD treatment is required at enrolment
 Other: ADHD Rating Scale-IV
ADHD Rating Scale-IV test

  Eligibility

Ages Eligible for Study:   6 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482026

Contacts
Contact: Sylvain RHEIMS, MD 472 35 70 44 ext +33 sylvain.rheims@chu-lyon.fr
Contact: Segolène GAILLARD 427 85 77 28 ext +33 segolene.gaillard@chu-lyon.fr

Locations
France
Service de Neurologie pédiatrique, CHU d'Amiens Recruiting
Amiens, France, 80054
Contact: Patrick Berquin, MD            
Principal Investigator: Patrick Berquin, MD            
Service de Neurologie Pédiatrique, CHU d'Angers Recruiting
Angers, France, 49033
Contact: Sylvie N'Guyen The Tich, MD            
Principal Investigator: Sylvie N'Guyen The Tich, MD            
Service de Neurologie pédiatrique, CHU de Besançon Recruiting
Besançon, France, 25030
Contact: Norbert Khayat, MD            
Principal Investigator: Norbert Khayat, MD            
Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer Recruiting
Bron, France, 69677
Contact: Sylvain Rheims            
Principal Investigator: Sylvain Rheims            
Institut des Epilepsies de l'Enfant et de l'Adolescent, Hôpital Femme Mère Enfant Recruiting
Bron, France, 69677
Contact: Alexis Arzimanoglou, MD            
Principal Investigator: Alexis Arzimanoglou, MD            
Service d'épileptologie pédiatrique, CHR de Chambéry Recruiting
Chambéry, France, 73011
Contact: Fabienne Dalmon, MD            
Principal Investigator: Fabienne Dalmon, MD            
Service de Neurologie pédiatrique, Hôpital de la Timone Recruiting
Marseille, France, 13385
Contact: Mathieu Milh, MD            
Principal Investigator: Mathieu Milh, MD            
Sub-Investigator: Nathalie Villeneuve, MD            
Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades Recruiting
Paris, France, 75743
Contact: Rima Nabbout, MD            
Principal Investigator: Rima Nabbout, MD            
Service de Neurologie Pédiatrique, Hôpital Robert-Debré Recruiting
Paris, France, 75019
Contact: Stéphane Auvin, MD            
Principal Investigator: Stéphane Auvin, MD            
Service de Pédiatrie, Hôpital Sud Recruiting
Rennes, France, 35203
Contact: Silvia Napuri, MD            
Principal Investigator: Silvia Napuri, MD            
Service de Neurologie Pédiatrique, Hôpital des Enfants Recruiting
Toulouse, France, 31059
Contact: Claude Cances, MD            
Principal Investigator: Claude Cances, MD            
Service de Neurologie Pédiatrique, CHU de Tours Recruiting
Tours, France, 37044
Contact: Pierre Castelnau, MD            
Principal Investigator: Pierre Castelnau, MD            
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
Principal Investigator: Sylvain RHEIMS, MD Service de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer, Hospices Civils de Lyon
  More Information

No publications provided

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01482026     History of Changes
Other Study ID Numbers: 2011.682/25
Study First Received: November 24, 2011
Last Updated: November 29, 2011
Health Authority: France: The Commission nationale de l’informatique et des libertés

Keywords provided by Hospices Civils de Lyon:
Epilepsy
Attention deficit
ADHD rating scale IV

Additional relevant MeSH terms:
Epilepsy
Attention Deficit Disorder with Hyperactivity
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Attention Deficit and Disruptive Behavior Disorders
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013