<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03244345</url>
  </required_header>
  <id_info>
    <org_study_id>2016-19</org_study_id>
    <secondary_id>2016-A00708-43</secondary_id>
    <nct_id>NCT03244345</nct_id>
  </id_info>
  <brief_title>Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies</brief_title>
  <official_title>Depression, Stress and Vulnerability Factors in Drug Resistant Focal Epilepsies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Psychiatric disturbances, notably depression, occur frequently as co-morbid conditions with&#xD;
      epilepsy. A complex, probably bidirectional relationship between epilepsy and depression has&#xD;
      been postulated. Both epilepsy and depression also interact with stressful life events, but&#xD;
      only some patients develop these disorders after a stressful event, indicating the&#xD;
      possibility of a &quot;vulnerable&quot; population. Animal and human studies have looked at the role of&#xD;
      brain derived neurotrophic factor (BDNF) in this context. Low serum and/or CSF levels of BDNF&#xD;
      are associated with higher incidence of depression, and thus indicate the vulnerable&#xD;
      population.&#xD;
&#xD;
      Animal studies of BDNF have looked specifically at the relation between epilepsy and&#xD;
      depression using a novel &quot;double hit&quot; design. After chronic stress exposure, measurement of&#xD;
      BDNF levels allowed identification of 2 sub-groups: a vulnerable population and&#xD;
      non-vulnerable population. A &quot;second hit&quot; of kainic acid induced status epilepticus (SE) was&#xD;
      then applied to both the vulnerable and non-vulnerable populations. Only the vulnerable&#xD;
      population exposed to SE developed a depression-like profile.&#xD;
&#xD;
      In a proof of concept approach we propose studying the relation between epilepsy, depression,&#xD;
      anxiety and stressful life events, using serum BDNF levels in patients with pharmacoresistant&#xD;
      epilepsy. Evaluation of epilepsy type and co-morbid psychiatric profile will be performed in&#xD;
      150 subjects. By comparing BDNF levels for different epilepsy subgroups to BDNF levels for&#xD;
      healthy subjects and for depressed subjects without epilepsy, we hope to identify whether&#xD;
      risk of co-morbid depression and/or anxiety in epilepsy may be predicted using BDNF levels.&#xD;
      In addition, in a subgroup of 25 patients, we propose a pilot study in which cortisol and&#xD;
      C-reactive protein will be measured in addition to BDNF.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 20, 2017</start_date>
  <completion_date type="Anticipated">February 20, 2021</completion_date>
  <primary_completion_date type="Anticipated">February 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Depression</measure>
    <time_frame>24 months</time_frame>
    <description>Score assessment of Becks Depression Inventory sacle</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Depression and Epilepsy</condition>
  <arm_group>
    <arm_group_label>Epileptic patient</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Self-measurement scale of sensitivity to stress/emotion</intervention_name>
    <description>Patient will answer self-questionner on Depression</description>
    <arm_group_label>Epileptic patient</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Definite diagnosis of epilepsy, of any type (partial or generalised) and at any stage&#xD;
             from diagnosis onwards&#xD;
&#xD;
          -  Known or unknown etiology (symptomatic or cryptogenic epilepsy)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychogenic non-epileptic seizures&#xD;
&#xD;
          -  Psychotic disorders and bipolar disorders&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Urielle DESALBRES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Aïleen Mc Gonigal, MD</last_name>
    <phone>+33491384995</phone>
    <email>aileen.mcgonigal@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hôpitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Aïleen Mc Gonigal, MD</last_name>
      <email>aileen.mcgonigal@ap-hm.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chu Tours</name>
      <address>
        <city>Tours</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Bertrand DE TOFFOL, MD/PhD</last_name>
      <email>bertrand.detoffol@univ-tours.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Epilepsies, Partial</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03244345
org study id: 2016-19
secondary id: 2016-A00708-43
nct id: NCT03244345
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Depression
time frame: 24 months
description: Score assessment of Becks Depression Inventory sacle
arm group label: Epileptic patient
arm group type: Experimental
intervention type: Behavioral
intervention name: Self-measurement scale of sensitivity to stress/emotion
description: Patient will answer self-questionner on Depression
arm group label: Epileptic patient
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Urielle DESALBRES
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Aïleen Mc Gonigal, MD
phone: +33491384995
email: aileen.mcgonigal@ap-hm.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Epilepsies, Partial
mesh term: Depression
mesh term: Depressive Disorder
sharing ipd: Undecided