Clinical Trial: Epilepsy and Mood Regulation Disorder in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy

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 un

Detailed Summary:
Sponsor: Hospices Civils de Lyon

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• 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).
• 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

Original Secondary Outcome: Same as current

Information By: Hospices Civils de Lyon

Dates:
Date Received: September 30, 2015
Date Started: March 2015
Date Completion: September 2017
Last Updated: October 2, 2015
Last Verified: September 2015