EpilepsyEPILETRENCT02568813
Epilepsy and Mood Regulation Disorder in Children
A study testing Multiscore Depression Inventory for Children scale in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 15 yearsHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- What is being tested?
- Multiscore Depression Inventory for Children scale
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteFrance
- Study dates
- 30 Mar 2015to 30 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 15 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hôpital Femme Mère Enfant
Bron, Rhône, 69500
Alexis ARZIMANOGLOU, Pr, (0)4 27 85 77 04 ext. +33, aarzimanoglou@orange.fr
Agathe LAURENT, PhD, (0)6 61 60 11 30 ext. +33, agathelaurent1977@gmail.com
About this study
Official title: Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy
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.
Read more
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.
- Conditions
- Epilepsy
- Being tested
- Multiscore Depression Inventory for Children scale
- Keywords
- epilepsy, depression, mood disorder, anxiety, cyclothymia, Behavioral neuropsychiatric features
- Medical subject headings
- Epilepsy, Depression, Mood Disorders, Anxiety Disorders, Cyclothymic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multiscore Depression Inventory for Children scaleBehavioural
Also called Revisited Children's Manifest Anxiety Scale, Kochman indicating a cyclothymia disorder Scale, Weschler Intelligence Scale for Children - 4th Edition
| Study group | Role | What they receive |
|---|---|---|
| Scales passation | Experimental | Not described Receives: Behavioral: Multiscore Depression Inventory for Children scale |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of children with new- or recent-onset epilepsy with a pathological score in a least one of the 3 scales
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
Measured: 18 months
Secondary outcomes (2)
Correlate pathological scores obtained with the type of epilepsy
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).
Measured: 18 months
Correlate pathological scores with the progression of epilepsy disease
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
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study start30 Mar 2015
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568813
- Sponsor's protocol ID
- 2013-834
- Acronym
- EPILETRE
- Status last verified
- Sep 2019
- First submitted
- 30 Sep 2015
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epilepsy and Mood Regulation Disorders: a Prospective and Longitudinal Study in Children With Newly Diagnosed Epilepsy
- ClinicalTrials.gov ID
- NCT02568813
- Acronym / sponsor ID
- EPILETRE / 2013-834
- Conditions
- Epilepsy
- Keywords
- epilepsy, depression, mood disorder, anxiety, cyclothymia, Behavioral neuropsychiatric features
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 30 Mar 2015 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 6 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scales passation | Experimental | Behavioral: Multiscore Depression Inventory for Children scale |
Who may qualify
- Ages
- 6 to 15 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multiscore Depression Inventory for Children scaleAlso: Revisited Children's Manifest Anxiety Scale, Kochman indicating a cyclothymia disorder Scale, Weschler Intelligence Scale for Children - 4th Edition | Behavioural | Scales passation |
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
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
2 secondary outcomes
Correlate pathological scores obtained with the type of epilepsy
Time frame: 18 months
Correlate pathological scores with the progression of epilepsy disease
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multiscore Depression Inventory for Children scale in people with Epilepsy, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis ARZIMANOGLOU, Pr ((0)4 27 85 77 04 ext. +33, aarzimanoglou@orange.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.