<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/NCT03247764</url>
  </required_header>
  <id_info>
    <org_study_id>Regist-EP and DP</org_study_id>
    <nct_id>NCT03247764</nct_id>
  </id_info>
  <brief_title>A Registration Study on Depression in Patients With Epilepsy</brief_title>
  <official_title>A Registration Study on Drug Treatment for Comorbid Depression in Patients With Epilepsy in East China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Zhongshan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Zhongshan Hospital</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The aim of this study is to register the drug treatment of depression in patients with&#xD;
      epilepsy in East China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the treatment rate for depression in epilepsy is unclear and the discordant voice of&#xD;
      choosing antidepressants for most doctors, this prospective observational cohort study was&#xD;
      designed to better understand the current situation of drug treatments in patients with the&#xD;
      comorbidity of epilepsy and depression in East China. The secondary outcome was to&#xD;
      investigate whether baseline depressive symptoms had an influence on seizure-control in&#xD;
      patients with epilepsy at follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">February 1, 2018</start_date>
  <completion_date type="Anticipated">January 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>the drug treatment rate of depression in patients with epilepsy</measure>
    <time_frame>6 months</time_frame>
    <description>the drug treatment rate at baseline and 6 months at follow-up</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the influence of depression on seizure-control</measure>
    <time_frame>6 months</time_frame>
    <description>whether depression at baseline affects seizure-control 6 months later</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">320</enrollment>
  <condition>Epilepsy</condition>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>patients with the comorbidity of epilepsy and depression</arm_group_label>
    <description>the clinical data, psychological assessment, and drug treatments will be investigated in patients with the comorbidity of epilepsy and depression</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients with the comorbidity of epilepsy and depression present to the neurology&#xD;
        department at 8 tertiary hospitals in East China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        The inclusion criteria were as follows: (1) age 18-75, no gender limited; (2) diagnosis of&#xD;
        epilepsy according to the definition by ILAE in 2014; (3) the score of 17-item Hamilton&#xD;
        Depression Rating Scale greater than 7; (4) Obtaining informed consent of participants. The&#xD;
        exclusion criteria were any of the following: (1) having psychiatric symptoms such as&#xD;
        hallucination or delusion; (2) progressive neurological diseases and malignant tumors; (3)&#xD;
        severe cognitive dysfunction (the score of MMSE less than 10).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Xin Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fudan University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Weifeng Peng, MD</last_name>
    <phone>862164041990</phone>
    <phone_ext>2976</phone_ext>
    <email>peng.weifeng@zs-hospital.sh.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Neurology, Huashan Hospital, Fudan University, Shanghai, China</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhen Hong, MD</last_name>
      <phone>86-021-52889999</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310009</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Meiping Ding, MD</last_name>
      <phone>86-0571-87783777</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Anhui Provincial Hospital</name>
      <address>
        <city>Hefei</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruobin Qian</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Nanjing Brain Hospital</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xiaoshan Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shanghai General Hospital</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ming Zhu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Suzhou University</name>
      <address>
        <city>Suzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chunfeng Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Wenzhou Medical University</name>
      <address>
        <city>Wenzhou</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Huiqin Xu</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 3, 2017</study_first_submitted>
  <study_first_submitted_qc>August 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>December 19, 2021</last_update_submitted>
  <last_update_submitted_qc>December 19, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>epilepsy</keyword>
  <keyword>depression</keyword>
  <keyword>drug treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Epilepsy</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
  </condition_browse>
  <!-- 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/NCT03247764
org study id: Regist-EP and DP
nct id: NCT03247764
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to register the drug treatment of depression in patients with
      epilepsy in East China.
As the treatment rate for depression in epilepsy is unclear and the discordant voice of
      choosing antidepressants for most doctors, this prospective observational cohort study was
      designed to better understand the current situation of drug treatments in patients with the
      comorbidity of epilepsy and depression in East China. The secondary outcome was to
      investigate whether baseline depressive symptoms had an influence on seizure-control in
      patients with epilepsy at follow-up.
observational model: Cohort
time perspective: Prospective
measure: the drug treatment rate of depression in patients with epilepsy
time frame: 6 months
description: the drug treatment rate at baseline and 6 months at follow-up
measure: the influence of depression on seizure-control
time frame: 6 months
description: whether depression at baseline affects seizure-control 6 months later
arm group label: patients with the comorbidity of epilepsy and depression
description: the clinical data, psychological assessment, and drug treatments will be investigated in patients with the comorbidity of epilepsy and depression
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Xin Wang, PhD
role: Principal Investigator
affiliation: Fudan University
last name: Weifeng Peng, MD
phone: 862164041990
phone ext: 2976
email: peng.weifeng@zs-hospital.sh.cn
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Epilepsy
mesh term: Depression
mesh term: Depressive Disorder