Depression and Epilepsy Clinical Trial
Official title:
Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies
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.
| Status | Recruiting |
| Enrollment | 150 |
| Est. completion date | February 20, 2021 |
| Est. primary completion date | February 20, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpitaux de Marseille | Marseille | |
| France | Chu Tours | Tours |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Depression | Score assessment of Becks Depression Inventory sacle | 24 months |