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ClinicalTrials.gov ID

NCT03244345

Lead Sponsor

Assistance Publique Hopitaux De MarseilleOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

150Estimated

Last Update Posted

Aug 9, 2017Actual

Start Date

Feb 20, 2017Actual

Primary Completion Date

Feb 20, 2020Estimated

Completion Date

Feb 20, 2021Estimated

Official Title

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

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.

• Depression and Epilepsy

• Self-measurement scale of sensitivity to stress/emotion

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

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

Primary Purpose

Diagnostic

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Assistance Publique Hopitaux De MarseilleOTHER

bertrand.detoffol@univ-tours.fr