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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 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: January 22, 2015
Last verified: January 2015
  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:


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: April 2016
Estimated Primary Completion Date: April 2016 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Completed
Amiens, France, 80054
Service de Neurologie Pédiatrique, CHU d'Angers Completed
Angers, France, 49033
Service de Neurologie pédiatrique, CHU de Besançon Completed
Besançon, France, 25030
Unité de Neurologie de l'Enfant et de l'Adolescent, Hôpital Pellegrin Completed
Bordeaux, France, 33076
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 de Neurologie Fonctionnelle et Epileptologie, Hôpital Neurologique Pierre Wertheimer Recruiting
Bron, France, 69677
Contact: Sylvain Rheims         
Principal Investigator: Sylvain Rheims         
Service d'épileptologie pédiatrique, CHR de Chambéry Completed
Chambéry, France, 73011
Cabinet Médical du Dr ISNARD Completed
Lyon, France, 69002
Service de Neurologie pédiatrique, Hôpital de la Timone Completed
Marseille, France, 13385
Service de Neurologie pédiatrique, Hôpital Neckert-Enfants malades Completed
Paris, France, 75743
Service de Neurologie Pédiatrique, Hôpital Robert-Debré Completed
Paris, France, 75019
Service de Pédiatrie, Hôpital Sud Completed
Rennes, France, 35203
Centre Référent des Epilepsies Rares, Hôpital de Hautepierre Completed
Strasbourg, France, 67098
Service de Neurologie Pédiatrique, Hôpital des Enfants Completed
Toulouse, France, 31059
Service de Neurologie Pédiatrique, CHU de Tours Completed
Tours, France, 37044
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: January 22, 2015
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:
Attention Deficit Disorder with Hyperactivity
Epilepsy
Attention Deficit and Disruptive Behavior Disorders
Brain Diseases
Central Nervous System Diseases
Mental Disorders
Mental Disorders Diagnosed in Childhood
Nervous System Diseases

ClinicalTrials.gov processed this record on May 21, 2015