Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Sponsor

Assistance Publique Hopitaux De Marseille (Other)

Overall Status

Unknown status

CT.gov ID

NCT03244345

Collaborator

(none)

150

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression and Epilepsy	Behavioral: Self-measurement scale of sensitivity to stress/emotion	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

Actual Study Start Date :

Feb 20, 2017

Anticipated Primary Completion Date :

Feb 20, 2020

Anticipated Study Completion Date :

Feb 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Epileptic patient	Behavioral: Self-measurement scale of sensitivity to stress/emotion Patient will answer self-questionner on Depression

Arm

Intervention/Treatment

Experimental: Epileptic patient

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

Patient will answer self-questionner on Depression

Outcome Measures

Primary Outcome Measures

Depression [24 months]
Score assessment of Becks Depression Inventory sacle

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Assistance Publique Hôpitaux de Marseille	Marseille		France	13354
2	Chu Tours	Tours		France

Sponsors and Collaborators

Assistance Publique Hopitaux De Marseille

Investigators

Study Director: Urielle DESALBRES, Assistance Publique Hôpitaux de Marseille

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Assistance Publique Hopitaux De Marseille

ClinicalTrials.gov Identifier:

NCT03244345

Other Study ID Numbers:

2016-19
2016-A00708-43

First Posted:

Aug 9, 2017

Last Update Posted:

Aug 9, 2017

Last Verified:

Aug 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 9, 2017