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Epilepsy and Mood Regulation Disorder in Children (EPILETRE)

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ClinicalTrials.gov Identifier: NCT02568813
Recruitment Status : Recruiting
First Posted : October 6, 2015
Last Update Posted : August 9, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

Epilepsy is a multifaceted disorder and a major public health problem. In addition to recurrent and unpredictable seizures, abnormalities in psychiatric status, cognition and social-adaptive behaviors are potential major sources of disability in children and adults with epilepsy disorders. Recent studies have unequivocally documented raised psychiatric comorbidities in children with epilepsy, particularly emotional regulation disorders such as depression and anxiety, as compared to both the general population and the children with other medical disorders, neurological and non-neurological. A prevalence of 12% to 35% has been reported, compared to 3-8% in the general population.

Major advances have begun to uncover the potential mediators of emotional regulation disorders and social comorbidities in epilepsy, but important gaps remain in the early detection, treatment and prevention of these disorders. A very small number of investigations have examined children with epilepsy at or near the time of diagnosis. This is a time during which the effects of chronic epilepsy, potential averse social effects of epilepsy, and other complicating aetiological effects are minimized.

Epilepsy syndromes provide a useful framework for considering the risk and type of emotional dysregulation comorbidities. But variability within and across syndromes needs to be taken into account thus requiring a strict phenotyping by specialists in the filed of pediatric epileptology. Retrospective studies, usually including patients with chronic epilepsies and suffering from a mixed spectrum of epilepsy syndromes introduce biases leading to rather disparate findings.

Are such disorders the result of common physiopathological mechanisms, which precede the development of the epilepsy? The link between an underlying brain disorder and psychiatric comorbidities has emerged in recent literature, with evidence based on studies in adults, suggesting bidirectional relations between epilepsy and neurobehavioural comorbidities. Emotional regulation disorders can follow the onset of epilepsy, but they can also precede it, thus serving as a possible risk factor. The clinical implication of such a bidirectional association is that neurobehavioural comorbidities might be present at diagnosis and even before epilepsy onset. There is a need for greater understanding of the causes of these conditions in younger people.

The degree to which specific epilepsy syndromes are associated with the relative risk of emotional dysregulation disorders in children with new- or recent-onset (within six months prior to enrolment) has rarely been comprehensively examined and represents the focus of the current investigation.

The investigators study will be based on a prospectively recruited cohort of 280 children/adolescents with recently diagnosed epilepsy. All participating centres dispose of the necessary competences for a precise diagnosis of the epilepsy syndromes and the tools for a per case appropriate aetiology screening. Following a first seizure children are usually first examined at hospital based emergency departments. Prompt referral to the epilepsy teams participating at the present study will significantly reduce the population biases and shortcuts encountered in studies that recruited patients with chronic epilepsy followed in tertiary care epilepsy units.

The investigators expect their results to provide a greater understanding of both the shared and the unique features of emotional regulation disorders, in relation to specific epilepsy categories defined on the basis of the underlying physiopathological mechanisms.

Such knowledge will also assist clinicians and families in the planning of both diagnosis and management resources.


Condition or disease Intervention/treatment
Epilepsy Behavioral: Multiscore Depression Inventory for Children scale

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy
Actual Study Start Date : March 30, 2015
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Epilepsy
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Scales passation Behavioral: Multiscore Depression Inventory for Children scale
Other Names:
  • Revisited Children's Manifest Anxiety Scale
  • Kochman indicating a cyclothymia disorder Scale
  • Weschler Intelligence Scale for Children - 4th Edition


Outcome Measures

Primary Outcome Measures :
  1. Number of children with new- or recent-onset epilepsy with a pathological score in a least one of the 3 scales [ Time Frame: 18 months ]

    The 3 scales are MDI-C ; R-CMAS and Kochman scale :

    • A standard score of >66 for MDI-C (Multiscore Depression Inventory for Children) indicating a depressive disorder;
    • A standard score of >60 or <40 for R-CMAS (Revisited Children's Manifest Anxiety Scale) indicating an anxiety disorder;
    • A score of >12 for Kochman indicating a cyclothymia disorder


Secondary Outcome Measures :
  1. Correlate pathological scores obtained with the type of epilepsy [ Time Frame: 18 months ]

    The same scoring system as for the primary end point will be used

    Type of epilepsy :

    • with or without (MRI-negative) detectable cerebral lesion;
    • focal idiopathic (genetic) epilepsy;
    • generalized idiopathic (genetic) epilepsy).

  2. Correlate pathological scores with the progression of epilepsy disease [ Time Frame: 18 months ]

    The same scoring system as for the primary end point will be used to evaluate the development, or progression, of emotional regulation disorders after 18 months of follow-up (constituted epilepsy);

    In each types of epilepsy, progression of the disease will be assessed by :

    • crises frequency
    • crises type


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • one of the following 3 epilepsy categories (focal structural epilepsy, with or without (MRI-negative) detectable cerebral lesion; focal idiopathic (genetic) epilepsy; generalized idiopathic (genetic) epilepsy).
  • Onset of epilepsy within the 6 months from enrolment.
  • Patients whose eventual antiepileptic drug treatments were not modified in the months preceding the neuropsychological and psychiatric evaluations.
  • Patients who give their consent to participate in the study and whose legal guardians have agreed to sign the written consent form.

Exclusion Criteria:

  • Patients younger than 5 years and 11 months or older than 15 years and 6 months.
  • Patients with a diagnosis of epilepsy, other than the types defined above.
  • Cognitive impairment, defined as a score of <70, based on WISC-IV verbal comprehension and perceptual reasoning scales.
  • Children with a confirmed diagnosis of a psychiatric disorder, other than those studied.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568813


Contacts
Contact: Alexis ARZIMANOGLOU, Pr (0)4 27 85 77 04 ext +33 aarzimanoglou@orange.fr
Contact: Agathe LAURENT,, PhD (0)6 61 60 11 30 ext +33 agathelaurent1977@gmail.com

Locations
France
Hôpital Femme Mère Enfant Recruiting
Bron, Rhône, France, 69500
Contact: Alexis ARZIMANOGLOU, Pr    (0)4 27 85 77 04 ext +33    aarzimanoglou@orange.fr   
Contact: Agathe LAURENT, PhD    (0)6 61 60 11 30 ext +33    agathelaurent1977@gmail.com   
Sponsors and Collaborators
Hospices Civils de Lyon
More Information

Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02568813     History of Changes
Other Study ID Numbers: 2013-834
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: August 9, 2017
Last Verified: August 2017

Keywords provided by Hospices Civils de Lyon:
epilepsy
depression
mood disorder
anxiety
cyclothymia
Behavioral neuropsychiatric features

Additional relevant MeSH terms:
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases