<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/NCT03230682</url>
  </required_header>
  <id_info>
    <org_study_id>KY2017-01</org_study_id>
    <nct_id>NCT03230682</nct_id>
  </id_info>
  <brief_title>Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder</brief_title>
  <official_title>Eealy Improvement Predicts Antidepressants Response in Adults With Major Depression Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Huashan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Huashan 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>
      Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale&#xD;
      (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can&#xD;
      arguably predict the remission at the 12th week. Our observation study including 80 MDD&#xD;
      patients will access resting-state function MRI to finding factors which infuencing early&#xD;
      improvemrnt, respone and remission of antidepressants.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">July 25, 2017</start_date>
  <completion_date type="Anticipated">July 11, 2018</completion_date>
  <primary_completion_date type="Anticipated">June 11, 2018</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>3 Months</target_duration>
  <primary_outcome>
    <measure>Early improvement</measure>
    <time_frame>the second week of treatment</time_frame>
    <description>obtain 20% decrease of HAMD-17</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response</measure>
    <time_frame>the 12th week of treatment</time_frame>
    <description>obtain 50% decrease of HAMD-17</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Major Depressive Disorder</condition>
  <arm_group>
    <arm_group_label>major depressive disorder</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>antidepressant</intervention_name>
    <description>regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)</description>
    <arm_group_label>major depressive disorder</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The han nationality who living in Shanghai, Zhejiang Province and Jiangsu Province&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  right-handed; HAMD-17 more than 17; diagnosed with MDD by the Structured Clinical&#xD;
             Interview for DSM-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients diagnosed with other condition in DSM-IV Axis I; pregnency; Thyroid disease;&#xD;
             Heart Disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Shi Shenxun, PhD</last_name>
    <phone>13816203171</phone>
    <email>shishenxun@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Dept. of Neurology, Huashan Hospital, Fudan University</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200040</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jie Tang</last_name>
      <phone>+8618818210880</phone>
      <email>tan11711@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wagner S, Engel A, Engelmann J, Herzog D, Dreimuller N, Muller MB, Tadic A, Lieb K. Early improvement as a resilience signal predicting later remission to antidepressant treatment in patients with Major Depressive Disorder: Systematic review and meta-analysis. J Psychiatr Res. 2017 Nov;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. Epub 2017 Jul 4.</citation>
    <PMID>28697423</PMID>
  </reference>
  <results_reference>
    <citation>Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.</citation>
    <PMID>19254516</PMID>
  </results_reference>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 26, 2017</study_first_posted>
  <last_update_submitted>July 25, 2017</last_update_submitted>
  <last_update_submitted_qc>July 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Huashan Hospital</investigator_affiliation>
    <investigator_full_name>Jianhui Fu</investigator_full_name>
    <investigator_title>Department of Neurology, Huashan Hospital</investigator_title>
  </responsible_party>
  <keyword>early improvement</keyword>
  <keyword>antidepressants</keyword>
  <keyword>major depression diorder</keyword>
  <keyword>resting-state fMRI</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depressive Disorder, Major</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Antidepressive Agents</mesh_term>
  </intervention_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/NCT03230682
org study id: KY2017-01
nct id: NCT03230682
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Early improvemrnt, decreased 20% in the 17 items of Hamilton Depression Rating Scale
      (HAMD-17) at the second week of the treatment of major depression disorder (MDD), can
      arguably predict the remission at the 12th week. Our observation study including 80 MDD
      patients will access resting-state function MRI to finding factors which infuencing early
      improvemrnt, respone and remission of antidepressants.
observational model: Cohort
time perspective: Prospective
measure: Early improvement
time frame: the second week of treatment
description: obtain 20% decrease of HAMD-17
measure: Response
time frame: the 12th week of treatment
description: obtain 50% decrease of HAMD-17
arm group label: major depressive disorder
intervention type: Drug
intervention name: antidepressant
description: regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)
arm group label: major depressive disorder
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 55 Years
healthy volunteers: No
last name: Shi Shenxun, PhD
phone: 13816203171
email: shishenxun@163.com
facility: 
status: Recruiting
contact: 
country: China
citation: Wagner S, Engel A, Engelmann J, Herzog D, Dreimuller N, Muller MB, Tadic A, Lieb K. Early improvement as a resilience signal predicting later remission to antidepressant treatment in patients with Major Depressive Disorder: Systematic review and meta-analysis. J Psychiatr Res. 2017 Nov;94:96-106. doi: 10.1016/j.jpsychires.2017.07.003. Epub 2017 Jul 4.
PMID: 28697423
citation: Szegedi A, Jansen WT, van Willigenburg AP, van der Meulen E, Stassen HH, Thase ME. Early improvement in the first 2 weeks as a predictor of treatment outcome in patients with major depressive disorder: a meta-analysis including 6562 patients. J Clin Psychiatry. 2009 Mar;70(3):344-53. doi: 10.4088/jcp.07m03780. Epub 2009 Feb 24.
PMID: 19254516
responsible party type: Principal Investigator
investigator affiliation: Huashan Hospital
investigator full name: Jianhui Fu
investigator title: Department of Neurology, Huashan Hospital
mesh term: Depression
mesh term: Depressive Disorder
mesh term: Depressive Disorder, Major
mesh term: Antidepressive Agents
sharing ipd: Undecided