Skip to content

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03244345
Enrollment
150
Registered
2017-08-09
Start date
2017-02-20
Completion date
2021-02-20
Last updated
2017-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression and Epilepsy

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.

Interventions

BEHAVIORALSelf-measurement scale of sensitivity to stress/emotion

Patient will answer self-questionner on Depression

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depression24 monthsScore assessment of Becks Depression Inventory sacle

Countries

France

Contacts

Primary ContactAïleen Mc Gonigal, MD
aileen.mcgonigal@ap-hm.fr+33491384995

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026