Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Primary Purpose
Depression and Epilepsy
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Self-measurement scale of sensitivity to stress/emotion
Sponsored by
About this trial
This is an interventional diagnostic trial for Depression and Epilepsy
Eligibility Criteria
Inclusion Criteria:
- Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
- Known or unknown etiology (symptomatic or cryptogenic epilepsy)
Exclusion Criteria:
- Psychogenic non-epileptic seizures
- Psychotic disorders and bipolar disorders
Sites / Locations
- Assistance Publique Hôpitaux de MarseilleRecruiting
- Chu Tours
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Epileptic patient
Arm Description
Outcomes
Primary Outcome Measures
Depression
Score assessment of Becks Depression Inventory sacle
Secondary Outcome Measures
Full Information
NCT ID
NCT03244345
First Posted
August 7, 2017
Last Updated
August 7, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT03244345
Brief Title
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Official Title
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 20, 2017 (Actual)
Primary Completion Date
February 20, 2020 (Anticipated)
Study Completion Date
February 20, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has been postulated. Both epilepsy and depression also interact with stressful life events, but only some patients develop these disorders after a stressful event, indicating the possibility of a "vulnerable" population. Animal and human studies have looked at the role of brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF are associated with higher incidence of depression, and thus indicate the vulnerable population.
Animal studies of BDNF have looked specifically at the relation between epilepsy and depression using a novel "double hit" design. After chronic stress exposure, measurement of BDNF levels allowed identification of 2 sub-groups: a vulnerable population and non-vulnerable population. A "second hit" of kainic acid induced status epilepticus (SE) was then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable population exposed to SE developed a depression-like profile.
In a proof of concept approach we propose studying the relation between epilepsy, depression, anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in 150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for healthy subjects and for depressed subjects without epilepsy, we hope to identify whether risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels. In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and C-reactive protein will be measured in addition to BDNF.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression and Epilepsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Epileptic patient
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Self-measurement scale of sensitivity to stress/emotion
Intervention Description
Patient will answer self-questionner on Depression
Primary Outcome Measure Information:
Title
Depression
Description
Score assessment of Becks Depression Inventory sacle
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage from diagnosis onwards
Known or unknown etiology (symptomatic or cryptogenic epilepsy)
Exclusion Criteria:
Psychogenic non-epileptic seizures
Psychotic disorders and bipolar disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aïleen Mc Gonigal, MD
Phone
+33491384995
Email
aileen.mcgonigal@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aïleen Mc Gonigal, MD
Email
aileen.mcgonigal@ap-hm.fr
Facility Name
Chu Tours
City
Tours
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bertrand DE TOFFOL, MD/PhD
Email
bertrand.detoffol@univ-tours.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
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