Clinical Trials Directory

Trials / Unknown

UnknownNCT03244345

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
150 (estimated)
Sponsor
Assistance Publique Hopitaux De Marseille · Academic / Other
Sex
All
Age
18 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALSelf-measurement scale of sensitivity to stress/emotionPatient will answer self-questionner on Depression

Timeline

Start date
2017-02-20
Primary completion
2020-02-20
Completion
2021-02-20
First posted
2017-08-09
Last updated
2017-08-09

Locations

2 sites across 1 country: France

Source: ClinicalTrials.gov record NCT03244345. Inclusion in this directory is not an endorsement.