Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Not Applicable

• Conditions: Depression and Epilepsy
• Interventions: Behavioral: Self-measurement scale of sensitivity to stress/emotion

• Registration Number: NCT03244345
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-20
• Status Verified: 2017-08
• Study First Submitted: 2017-08-07
• Study First Submitted QC: 2017-08-07
• Last Update Submitted: 2017-08-07
• Study First Posted: 2017-08-09
• Last Update Posted: 2017-08-09
• Primary Completion: 2020-02-20
• Study Completion: 2021-02-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epileptic patient	Self-measurement scale of sensitivity to stress/emotion	-

Primary Outcome Measures

Name	Time	Method
Depression	24 months	Score assessment of Becks Depression Inventory sacle

Trial Locations

Locations (2)

Chu Tours; 🇫🇷 Tours, France

Assistance Publique Hôpitaux de Marseille; 🇫🇷 Marseille, France