<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/NCT03026595</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-047</org_study_id>
    <nct_id>NCT03026595</nct_id>
  </id_info>
  <brief_title>The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China</brief_title>
  <official_title>The Profile of the Depression and it's Intervention Strategy in Patients With Parkinson's Disease in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Depression is considered to be the most common neuropsychiatric disturbance of PD. In this&#xD;
      study, investigators will summarize the treatment profile of PD depression to see if PD&#xD;
      depression is properly treated according to guideline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Depression is considered to be the most common neuropsychiatric disturbance of PD. Prevalence&#xD;
      rates of depressive disorders in Parkinson's disease(PD) vary widely across studies, ranging&#xD;
      from 2.7% to more than 90%. A systematic review of the 36 articles concerning PD and&#xD;
      depression indicates that the weighted frequency of depressive PD was 52%.&#xD;
&#xD;
      Investigators' previous study on non-motor symptoms in 81 Chinese PD patients demonstrated&#xD;
      that prevalence of loss of interest and depression(sadness) were 48.7% and 36.7% by Non-motor&#xD;
      symptoms questionnaire (NMSQuest) separately, which was similar to average global data. But&#xD;
      another Chinese data published in 2008 showed that the prevalence of depression in PD&#xD;
      patients was only 12%, no statistical difference with controls(2%). Thus, investigators plan&#xD;
      to initiate a larger study to understand if PD depression in China is similar to it in&#xD;
      western countries.&#xD;
&#xD;
      Depression would occur at the early stage of the disease or proceed the motor symptoms,&#xD;
      usually accompanied with other non-motor symptoms including apathy, sleep disorder, cognitive&#xD;
      impairment, and etc. The effects of depression on quality of life might refer to a wider&#xD;
      range. There is lack of solid data to reveal the harm of depression on quality of life of PD&#xD;
      patients and caregivers. In clinical practice, the disease burden of PD depression is usually&#xD;
      underestimated by physicians and patients.&#xD;
&#xD;
      Although PD depression affects QoL of patients and caregivers, PD depression would be&#xD;
      relieved by medication, which was clearly recommended by international and Chinese PD&#xD;
      guidelines. But the PD depression treatment status in Chinese clinical practice is not&#xD;
      systematically analyzed before. In this study, investigator will summarize the treatment&#xD;
      profile of PD depression to see if PD depression is properly treated according to guideline.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Parkinson Disease</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>no intervention</intervention_name>
    <description>no intervention</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The estimated proportion of depression in patients with PD is around 50%. With 500&#xD;
        patients, the length of 95% CI of proportion of depression in PD patients will be less than&#xD;
        0.09 (the widest 95% confidence interval 0.088 will be attained only when the estimated&#xD;
        proportion is 50%).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic&#xD;
             criteria for depression)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to understand or answer questions for any reason，that would interfere our&#xD;
             assessment.&#xD;
&#xD;
          -  Participate in a concurrent clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Zhenguo Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mingzhu Zhou</last_name>
    <phone>15021628699</phone>
    <email>estherzhoumz@aliyun.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Neurology,Nanjing Brain Hospital,Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Weiguo Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Longhua Hospital, Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Canxin Yuan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Department of Neurology, Shanghai Tongji Hospital, Tongji University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Linjing Jin</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongshan Hospital &amp; Shanghai Medical College, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lirong Jin</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Gan J, Zhou M, Chen W, Liu Z. Non-motor symptoms in Chinese Parkinson's disease patients. J Clin Neurosci. 2014 May;21(5):751-4. doi: 10.1016/j.jocn.2013.07.015. Epub 2013 Sep 11.</citation>
    <PMID>24411328</PMID>
  </reference>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 6, 2018</last_update_submitted>
  <last_update_submitted_qc>May 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</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>Parkinson Disease</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/NCT03026595
org study id: XH-16-047
nct id: NCT03026595
lead sponsor: 
has dmc: No
Depression is considered to be the most common neuropsychiatric disturbance of PD. In this
      study, investigators will summarize the treatment profile of PD depression to see if PD
      depression is properly treated according to guideline.
Depression is considered to be the most common neuropsychiatric disturbance of PD. Prevalence
      rates of depressive disorders in Parkinson's disease(PD) vary widely across studies, ranging
      from 2.7% to more than 90%. A systematic review of the 36 articles concerning PD and
      depression indicates that the weighted frequency of depressive PD was 52%.

      Investigators' previous study on non-motor symptoms in 81 Chinese PD patients demonstrated
      that prevalence of loss of interest and depression(sadness) were 48.7% and 36.7% by Non-motor
      symptoms questionnaire (NMSQuest) separately, which was similar to average global data. But
      another Chinese data published in 2008 showed that the prevalence of depression in PD
      patients was only 12%, no statistical difference with controls(2%). Thus, investigators plan
      to initiate a larger study to understand if PD depression in China is similar to it in
      western countries.

      Depression would occur at the early stage of the disease or proceed the motor symptoms,
      usually accompanied with other non-motor symptoms including apathy, sleep disorder, cognitive
      impairment, and etc. The effects of depression on quality of life might refer to a wider
      range. There is lack of solid data to reveal the harm of depression on quality of life of PD
      patients and caregivers. In clinical practice, the disease burden of PD depression is usually
      underestimated by physicians and patients.

      Although PD depression affects QoL of patients and caregivers, PD depression would be
      relieved by medication, which was clearly recommended by international and Chinese PD
      guidelines. But the PD depression treatment status in Chinese clinical practice is not
      systematically analyzed before. In this study, investigator will summarize the treatment
      profile of PD depression to see if PD depression is properly treated according to guideline.
observational model: Other
time perspective: Cross-Sectional
measure: The incidence of depression in patients of Parkinson's disease (DSM-5 diagnostic criteria for depression)
time frame: through study completion, an average of 1 year
intervention type: Other
intervention name: no intervention
description: no intervention
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhenguo Liu
role: Principal Investigator
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
last name: Mingzhu Zhou
phone: 15021628699
email: estherzhoumz@aliyun.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: China
citation: Gan J, Zhou M, Chen W, Liu Z. Non-motor symptoms in Chinese Parkinson's disease patients. J Clin Neurosci. 2014 May;21(5):751-4. doi: 10.1016/j.jocn.2013.07.015. Epub 2013 Sep 11.
PMID: 24411328
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: Undecided