<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/NCT02191384</url>
  </required_header>
  <id_info>
    <org_study_id>ASLST-MDD-Ⅱa-1401</org_study_id>
    <secondary_id>2012ZX09303-003</secondary_id>
    <nct_id>NCT02191384</nct_id>
  </id_info>
  <brief_title>Comparison of Orcinoside With Placebo in Treatment of MDD</brief_title>
  <official_title>Proof Of Concept Study of Orcinoside in the Treatment of Major Depressive Disorder(MDD): a Randomized, Double-Blind, Placebo-Paralleled,Dose-Finding, Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Kun Ming KingBio Biotechnology Co. LTD</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Shanghai Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Orcinoside Capsule in different doses are&#xD;
      effective in the treatment of Depression.&#xD;
&#xD;
      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in&#xD;
      the Chinese Patients with Depression.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 9, 2016</completion_date>
  <primary_completion_date type="Actual">March 9, 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The change of total score from baseline in MADRS and HAMD scale</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate and remission rate</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decreasing rate from baseline in MADRS</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>decreasing rate from baseline in HAMD scale</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>change from baseline in HAMA</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CGI(CGI-S,CGI-I)</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>sleep VAS scale.</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>vital sign</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>AE(adverse events)</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>laboratory examination</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>ECG</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>C-SSRS</measure>
    <time_frame>6 weeks</time_frame>
  </other_outcome>
  <number_of_arms>7</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Major Depressive Disorder (MDD)</condition>
  <arm_group>
    <arm_group_label>Orcinoside 25mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcinoside 50mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcinoside 100mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcinoside 200mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcinoside 400mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Orcinoside 600mg per day</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Orcinoside</intervention_name>
    <description>oral, twice per day</description>
    <arm_group_label>Orcinoside 100mg per day</arm_group_label>
    <arm_group_label>Orcinoside 200mg per day</arm_group_label>
    <arm_group_label>Orcinoside 25mg per day</arm_group_label>
    <arm_group_label>Orcinoside 400mg per day</arm_group_label>
    <arm_group_label>Orcinoside 50mg per day</arm_group_label>
    <arm_group_label>Orcinoside 600mg per day</arm_group_label>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult with primary diagnosis of major depressive disorder based on the criteria of&#xD;
             DSM-IV-TR, single episode or recurrent episode, not accompanied with psychotic&#xD;
             symptoms. Coding of diagnosis included:&#xD;
&#xD;
        296.21 MDD single episode, mild 296.22 MDD single episode, moderate 296.31 MDD recurrent&#xD;
        episode, mild 296.32 MDD recurrent episode, moderate&#xD;
&#xD;
          -  The subject is an outpatient.&#xD;
&#xD;
          -  The subject is a man or woman,aged≥18 and ≤65 years.&#xD;
&#xD;
          -  The total score of HAMD-17 is ≥18 and ≤24 in both screening visit and baseline visit.&#xD;
&#xD;
          -  The subject is willing to take birth control measures during study period and one&#xD;
             month after study.&#xD;
&#xD;
          -  The subject understands and consents to takes part in this clinical trials. The&#xD;
             subjects should sign informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subject has a significant risk of suicide according to the investigator's opinion&#xD;
             or has a score ≥3 on item 3(suicide assessment) of the HAMD or has made a suicide&#xD;
             attempt.&#xD;
&#xD;
          -  The subject has a current DSM-Ⅳ-TR axisⅠpsychiatric diagnosis other than depression.&#xD;
&#xD;
          -  When the HAMD17 score of baseline visit compares with the screening visit, the&#xD;
             decreasing rate is ≥25%.&#xD;
&#xD;
          -  The subject has a current diagnosis or history of depression due to any other&#xD;
             psychotic disorder or a general medical condition, bipolar disorder, or depression&#xD;
             accompanied with psychotic symptoms.&#xD;
&#xD;
          -  Any unstable cardiovascular, hepatic, renal, endocrine(thyroid gland dysfunction),&#xD;
             blood,or other medical disease. Had a history of seizure disorder or other brain&#xD;
             organic disorders.&#xD;
&#xD;
          -  The subject has a diagnosis of alcohol or other substance abuse or dependence at least&#xD;
             1 years prior to the baseline visit.&#xD;
&#xD;
          -  Known hypersensitivity to Common Curculigo Rhizome or other drugs.&#xD;
&#xD;
          -  Women who were pregnant, breast-feeding, or planning to become pregnant during study.&#xD;
             Men who have request to fertility within half of year.&#xD;
&#xD;
          -  Clinically significant electrocardiographic(ECG) abnormalities or abnormal laboratory&#xD;
             values(eg. Hepatic function above 1.5 times of clinical toplimit, renal function above&#xD;
             toplimit, blood glucose above toplimit, cardiac troponin abnormal, thyroid gland&#xD;
             examine index significantly abnormal).&#xD;
&#xD;
          -  The subject uses antidepressant drug normally before 2 weeks of screening, and stops&#xD;
             using psychotropic drug less than 7 half-life period (monoamine oxidase inhibitor more&#xD;
             than 2 weeks, fluoxetine more than 1 month).&#xD;
&#xD;
          -  The subject has accepted electroconvulsive therapy within 3months.&#xD;
&#xD;
          -  The subject has accepted system psychotherapy within 3 months.&#xD;
&#xD;
          -  The compliance of the subject is poor.&#xD;
&#xD;
          -  The subject has participated in a drug clinical trial within 30 days before screening.&#xD;
&#xD;
          -  The investigator think the subject is unsuitable to enrol in this clinical trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Huafang LI, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking University Sixth Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guangzhou Brain Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510370</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hebei Province Mental Health Center</name>
      <address>
        <city>Baoding</city>
        <state>Hebei</state>
        <zip>071000</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuhan Mental Health Center</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanjing Brain Hospital</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wuxi Mental Health Center</name>
      <address>
        <city>Wuxi</city>
        <state>Jiangsu</state>
        <zip>214151</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>the first affiliated hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Xi'an Mental Health Center</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>First Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wang ZH, Huang J, Ma XC, Li GY, Ma YP, Li N, Wang JH. Phenolic glycosides from Curculigo orchioides Gaertn. Fitoterapia. 2013 Apr;86:64-9. doi: 10.1016/j.fitote.2013.01.008. Epub 2013 Jan 23.</citation>
    <PMID>23353659</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>July 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 16, 2014</study_first_posted>
  <last_update_submitted>September 21, 2021</last_update_submitted>
  <last_update_submitted_qc>September 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Mental Health Center</investigator_affiliation>
    <investigator_full_name>LI, Huafang</investigator_full_name>
    <investigator_title>Executive Director of MICT</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Depressive Disorder, Major</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/NCT02191384
org study id: ASLST-MDD-Ⅱa-1401
secondary id: 2012ZX09303-003
nct id: NCT02191384
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study is to determine whether Orcinoside Capsule in different doses are
      effective in the treatment of Depression.

      And to explore the preliminary information of safety and efficacy of Orcinoside Capsule in
      the Chinese Patients with Depression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: The change of total score from baseline in MADRS and HAMD scale
time frame: 6 weeks
measure: response rate and remission rate
time frame: 6 weeks
measure: decreasing rate from baseline in MADRS
time frame: 6 weeks
measure: decreasing rate from baseline in HAMD scale
time frame: 6 weeks
measure: change from baseline in HAMA
time frame: 6 weeks
measure: CGI(CGI-S,CGI-I)
time frame: 6 weeks
measure: sleep VAS scale.
time frame: 6 weeks
measure: vital sign
time frame: 6 weeks
measure: AE(adverse events)
time frame: 6 weeks
measure: laboratory examination
time frame: 6 weeks
measure: ECG
time frame: 6 weeks
measure: C-SSRS
time frame: 6 weeks
arm group label: Orcinoside 25mg per day
arm group type: Experimental
arm group label: Orcinoside 50mg per day
arm group type: Experimental
arm group label: Orcinoside 100mg per day
arm group type: Experimental
arm group label: Orcinoside 200mg per day
arm group type: Experimental
arm group label: Orcinoside 400mg per day
arm group type: Experimental
arm group label: Orcinoside 600mg per day
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Orcinoside
description: oral, twice per day
arm group label: Orcinoside 100mg per day
arm group label: Orcinoside 200mg per day
arm group label: Orcinoside 25mg per day
arm group label: Orcinoside 400mg per day
arm group label: Orcinoside 50mg per day
arm group label: Orcinoside 600mg per day
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Huafang LI, MD PhD
role: Principal Investigator
affiliation: Shanghai Mental Health Center
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
citation: Wang ZH, Huang J, Ma XC, Li GY, Ma YP, Li N, Wang JH. Phenolic glycosides from Curculigo orchioides Gaertn. Fitoterapia. 2013 Apr;86:64-9. doi: 10.1016/j.fitote.2013.01.008. Epub 2013 Jan 23.
PMID: 23353659
responsible party type: Principal Investigator
investigator affiliation: Shanghai Mental Health Center
investigator full name: LI, Huafang
investigator title: Executive Director of MICT
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Depressive Disorder, Major