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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03244345
Other study ID # 2016-19
Secondary ID 2016-A00708-43
Status Recruiting
Phase N/A
First received August 7, 2017
Last updated August 7, 2017
Start date February 20, 2017
Est. completion date February 20, 2021

Study information

Verified date August 2017
Source Assistance Publique Hopitaux De Marseille
Contact Aïleen Mc Gonigal, MD
Phone +33491384995
Email aileen.mcgonigal@ap-hm.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Intervention

Behavioral:
Self-measurement scale of sensitivity to stress/emotion
Patient will answer self-questionner on Depression

Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille
France Chu Tours Tours

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Depression Score assessment of Becks Depression Inventory sacle 24 months