Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies

NCT ID: NCT03244345

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-20
• Study Completion Date: 2021-02-20

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.

Conditions

Depression and Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Epileptic patient

Group Type: EXPERIMENTAL

Self-measurement scale of sensitivity to stress/emotion

Intervention Type: BEHAVIORAL

Patient will answer self-questionner on Depression

Interventions

Self-measurement scale of sensitivity to stress/emotion

Patient will answer self-questionner on Depression

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

Assistance Publique Hôpitaux de Marseille

Marseille, , France

Site Status: RECRUITING

Chu Tours

Tours, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Aïleen Mc Gonigal, MD

Role: CONTACT

aileen.mcgonigal@ap-hm.fr

+33491384995

Facility Contacts

Aïleen Mc Gonigal, MD

Role: primary

aileen.mcgonigal@ap-hm.fr

Bertrand DE TOFFOL, MD/PhD

Role: primary

bertrand.detoffol@univ-tours.fr

Other Identifiers

2016-A00708-43

Identifier Type: OTHER

Identifier Source: secondary_id

2016-19

Identifier Type: -

Identifier Source: org_study_id