Ignite Creation Date:
2024-05-06 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 12:29 PM
Study NCT ID:
NCT03244345
Status:
UNKNOWN
Last Update Posted:
2017-08-09
First Post:
2017-08-07
Brief Title:
Depression Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Sponsor:
Assistance Publique Hopitaux De Marseille
Organization:
Assistance Publique Hopitaux De Marseille
Study Overview
Official Title:
Depression Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 andor 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
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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2016-A00708-43 | OTHER | IDRCB | None |