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Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

P

Public Assistance-Hospitals of Marseille (AP-HM)

Status

Unknown

Conditions

Depression and Epilepsy

Treatments

Behavioral: Self-measurement scale of sensitivity to stress/emotion

Study type

Interventional

Funder types

Other

Identifiers

NCT03244345
2016-19
2016-A00708-43 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

Epileptic patient
Experimental group
Treatment:
Behavioral: Self-measurement scale of sensitivity to stress/emotion

Trial contacts and locations

2

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Central trial contact

Aïleen Mc Gonigal, MD

Data sourced from clinicaltrials.gov

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