<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/NCT03294525</url>
  </required_header>
  <id_info>
    <org_study_id>001</org_study_id>
    <nct_id>NCT03294525</nct_id>
  </id_info>
  <brief_title>Towards Neurobiology-based Diagnosis and Treatment of Affective Disorders</brief_title>
  <official_title>Clinical Psychopharmacology Division</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project is a multi-center, prospective cohort study. The study's total targeted&#xD;
      enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy&#xD;
      controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at&#xD;
      baseline visit are to be assigned to one of the second-generation antidepressant drugs,&#xD;
      including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on&#xD;
      investigators' clinical practice. Initial treatment consists of a 8-week course with one of&#xD;
      these monotherapies. Patients who meet criteria for full remission are followed for a&#xD;
      22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are&#xD;
      offered another 8 weeks of acute treatment, including combination therapy or switching to&#xD;
      other antidepressant based on investigators' clinical practice. The clinical assessment&#xD;
      (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and&#xD;
      Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale&#xD;
      (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI,&#xD;
      genetics, neurochemistry, and immunology) were conducted to identify the biomarkers&#xD;
      associated with diagnosis, treatment efficacy prediction of depression. Among the 400&#xD;
      patients, about 100 patients receive MRI scans at baseline and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Anticipated">August 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>reduction in HAMD total scores</measure>
    <time_frame>8 weeks</time_frame>
    <description>reduction more than 50% was regarded as response</description>
  </primary_outcome>
  <primary_outcome>
    <measure>remision</measure>
    <time_frame>8 weeks</time_frame>
    <description>HAMD total score less than 7</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Affective Disorder</condition>
  <arm_group>
    <arm_group_label>Escitalopram-for MDD</arm_group_label>
    <description>Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Duloxetine-for MDD</arm_group_label>
    <description>Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mirtazepine-for MDD</arm_group_label>
    <description>Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>other antidepressant-for MDD</arm_group_label>
    <description>Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Escitalopram Pill</intervention_name>
    <description>escitalopram 10~20mg/day</description>
    <arm_group_label>Escitalopram-for MDD</arm_group_label>
    <other_name>Lexapro</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Duloxetine</intervention_name>
    <description>duloxetine 30~120mg/day</description>
    <arm_group_label>Duloxetine-for MDD</arm_group_label>
    <other_name>Cymbalta</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mirtazapine Pill</intervention_name>
    <description>Mirtazapine 15~45mg/day</description>
    <arm_group_label>Mirtazepine-for MDD</arm_group_label>
    <other_name>Remeron</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Other Antidepressants</intervention_name>
    <arm_group_label>other antidepressant-for MDD</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood samples were collected by venepuncture.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with major depressive disorder&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Patients with depression&#xD;
&#xD;
          -  The inclusion criteria for depressed patients were: male or female outpatients aged&#xD;
             between 18 and 55 years old&#xD;
&#xD;
          -  Currently in acute depressive episode&#xD;
&#xD;
          -  Total HAMD-17 score≥14 at baseline visit.&#xD;
&#xD;
          -  The diagnosis of depression was confirmed by a trained psychiatrists using the&#xD;
             Mini-International Neuropsychiatric Interview (MINI).&#xD;
&#xD;
          -  The patients participating in imaging scans should additionally satisfy: not taking&#xD;
             psychiatric drugs within last two weeks (except for benzodiazepine) or fluoxetine last&#xD;
             one month&#xD;
&#xD;
          -  Not receiving ECT within last 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to complete the questionnaire and psychological assessment independently&#xD;
&#xD;
          -  Significant cognitive impairments determined by system mental examination and&#xD;
             inability to sign an informed consent form&#xD;
&#xD;
          -  Past or presently suffering from other psychiatric disorders, alcohol and drug&#xD;
             dependence&#xD;
&#xD;
          -  Suffering from major physical diseases, such as cardiovascular and cerebrovascular&#xD;
             diseases, respiratory diseases, kidney disease, cancer and so on; personality disorder&#xD;
&#xD;
          -  Intellectual disabilities&#xD;
&#xD;
          -  Suicidal behavior&#xD;
&#xD;
          -  Being participating in other studies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tianmei Si, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sixth hospital of beijing university</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yunai Su, PhD</last_name>
    <phone>010-62723761</phone>
    <email>suyunai@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Institute of mental health, Peking University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tianmei Si, PhD.</last_name>
      <phone>8610-82801960</phone>
      <email>si.tian-mei@163.com</email>
    </contact>
    <investigator>
      <last_name>Tianmei Si, PhD.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>May 24, 2016</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 27, 2017</study_first_posted>
  <last_update_submitted>August 24, 2021</last_update_submitted>
  <last_update_submitted_qc>August 24, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking University</investigator_affiliation>
    <investigator_full_name>Si Tianmei</investigator_full_name>
    <investigator_title>Clinical Psychopharmacology Division</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mood Disorders</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duloxetine Hydrochloride</mesh_term>
    <mesh_term>Mirtazapine</mesh_term>
    <mesh_term>Antidepressive Agents</mesh_term>
    <mesh_term>Escitalopram</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03294525
org study id: 001
nct id: NCT03294525
lead sponsor: 
has dmc: No
The project is a multi-center, prospective cohort study. The study's total targeted
      enrollment is 400 first-episode patients with major depressive disorder (MDD) and 400 healthy
      controls.
Four hundred patients with a primary diagnosis of depression and HAMD-17 scores ≥14 at
      baseline visit are to be assigned to one of the second-generation antidepressant drugs,
      including escitalopram, duloxetine, mirtazapine, paroxetine, sertraline, etc based on
      investigators' clinical practice. Initial treatment consists of a 8-week course with one of
      these monotherapies. Patients who meet criteria for full remission are followed for a
      22-month follow-up phase to monitor for depression recurrence. Patients who do not remit are
      offered another 8 weeks of acute treatment, including combination therapy or switching to
      other antidepressant based on investigators' clinical practice. The clinical assessment
      (Hamilton Depression Rating Scale(HAMD)/ Clinical general impression (CGI) /the Positive and
      Negative Affect Schedule (PANAS) /subtypes of depression, Dimensional Anhedonia Rating Scale
      (DARS) , etc), early life stress, neuropsychological test, and biological examination (MRI,
      genetics, neurochemistry, and immunology) were conducted to identify the biomarkers
      associated with diagnosis, treatment efficacy prediction of depression. Among the 400
      patients, about 100 patients receive MRI scans at baseline and after treatment.
observational model: Cohort
time perspective: Prospective
measure: reduction in HAMD total scores
time frame: 8 weeks
description: reduction more than 50% was regarded as response
measure: remision
time frame: 8 weeks
description: HAMD total score less than 7
arm group label: Escitalopram-for MDD
description: Eligible patients were assigned to escitalopram treatment based on investigators' clinical practice.
arm group label: Duloxetine-for MDD
description: Eligible patients were assigned to duloxetine treatment based on investigators' clinical practice.
arm group label: Mirtazepine-for MDD
description: Eligible patients were assigned to mirtazepine treatment based on investigators' clinical practice.
arm group label: other antidepressant-for MDD
description: Eligible patients were assigned to other antidepressant treatment (including sertraline, paroxetine, fluoxetine, venlafaxine, etc) based on investigators' clinical practice.
intervention type: Drug
intervention name: Escitalopram Pill
description: escitalopram 10~20mg/day
arm group label: Escitalopram-for MDD
other name: Lexapro
intervention type: Drug
intervention name: Duloxetine
description: duloxetine 30~120mg/day
arm group label: Duloxetine-for MDD
other name: Cymbalta
intervention type: Drug
intervention name: Mirtazapine Pill
description: Mirtazapine 15~45mg/day
arm group label: Mirtazepine-for MDD
other name: Remeron
intervention type: Drug
intervention name: Other Antidepressants
arm group label: other antidepressant-for MDD
Blood samples were collected by venepuncture.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Tianmei Si, PhD
role: Principal Investigator
affiliation: Sixth hospital of beijing university
last name: Yunai Su, PhD
phone: 010-62723761
email: suyunai@163.com
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking University
investigator full name: Si Tianmei
investigator title: Clinical Psychopharmacology Division
mesh term: Mood Disorders
mesh term: Duloxetine Hydrochloride
mesh term: Mirtazapine
mesh term: Antidepressive Agents
mesh term: Escitalopram
sharing ipd: No