<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/NCT04498897</url>
  </required_header>
  <id_info>
    <org_study_id>VTX-RCT</org_study_id>
    <nct_id>NCT04498897</nct_id>
  </id_info>
  <brief_title>Vortioxetine for Treatment of Depressive Mood and Alcohol Use</brief_title>
  <official_title>A Randomized, Double-Blind, Placebo-Controlled Trial of Vortioxetine for Depressive Mood and Alcohol Use in Adults With Major Depressive Disorder and Alcohol Use Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University Seoul Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hanyang University Seoul Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double-blinded, placebo-controlled, multicenter study. A total of 128&#xD;
      subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. Subjects&#xD;
      will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment&#xD;
      group. Four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8)&#xD;
      compliance, depression symptoms, and alcohol craving will be assessed.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigational product&#xD;
&#xD;
        -  baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate*&#xD;
&#xD;
        -  First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate*&#xD;
&#xD;
        -  Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate*&#xD;
&#xD;
             -  Acamprosate 666 mg bid for bodyweight &lt; 60 kg; Acamprosate 666 mg tid for&#xD;
                bodyweight ≥ 60 kg&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 25, 2019</start_date>
  <completion_date type="Anticipated">April 4, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 4, 2021</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>
    <intervention_model_description>A randomized, placebo-controlled study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>Double-blinded study</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>K-MADRS</measure>
    <time_frame>From baseline for 8 weeks</time_frame>
    <description>Korean-Version of the Montgomery-Asberg Depression Rating Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OCDS-K</measure>
    <time_frame>from baseline for 8 weeks</time_frame>
    <description>Korean version of the Obsessive Compulsive Drinking Scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Depressive Disorder, Major</condition>
  <condition>Alcoholism</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Vortioxetine + Acamprosate</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo + Acamprosate</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vortioxetine</intervention_name>
    <description>Baseline: Vortioxetine 10mg (or placebo) + Acamprosate&#xD;
First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate&#xD;
Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acamprosate</intervention_name>
    <description>Baseline: Vortioxetine 10mg (or placebo) + Acamprosate&#xD;
First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate&#xD;
Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate</description>
    <arm_group_label>Placebo Group</arm_group_label>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects who are able to understand the study and comply with all study procedures and&#xD;
             willing to provide written informed consent prior to screening&#xD;
&#xD;
          -  Male and female subjects aged 19 to 65 years old&#xD;
&#xD;
          -  Diagnosed to have major depressive disorder and alcohol use disorder based on&#xD;
             DSM(Diagnostic and Statistical Manual of Mental Disorders)-5 by two separate&#xD;
             psychiatrists.&#xD;
&#xD;
          -  MADRS(Montgomery Åsberg Depression Rating Scale) ≥ 26 at baseline&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects considered not safe to participate in the study (e.g. who has suicidal&#xD;
             thoughts)&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  Subjects with serious or unstable disease&#xD;
&#xD;
          -  Clinical or laboratory signs of on-going hypothyroidism&#xD;
&#xD;
          -  History of organic mental disorder, schizophrenia spectrum disorder, bipolar disorder,&#xD;
             or substance abuse within 12 months (except for alcohol or nicotine abuse)&#xD;
&#xD;
          -  Administration of antidepressant (MAOIs, SSRIs, SNRIs, TCAs) including vortioxetine&#xD;
             and anti-craving medications (acamprosate, naltrexone) within 2 weeks from screening&#xD;
&#xD;
          -  Administration of antipsychotic, anti-manic drugs, dopamine antagonists, anxiolytics&#xD;
             (zolpidem more than 10mg, Benzodiazepine lorazepam equivalent dosage more than 2mg or&#xD;
             used as alcohol withdrawal treatment) within 2 weeks from screening&#xD;
&#xD;
          -  Administration of anti-depressant, fluoxetine, within 5 weeks from screening&#xD;
&#xD;
          -  Subjects in need of an alcohol detoxification treatment&#xD;
&#xD;
          -  Subjects in need of a hospitalization care&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sungwon Roh</last_name>
    <role>Principal Investigator</role>
    <affiliation>swroh@hanyang.ac.kr</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ji-eun Kim</last_name>
    <phone>82-2-2290-8422</phone>
    <email>eva.jieun.kim@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Sungwon Roh</last_name>
    <phone>82-2-2290-8422</phone>
    <email>swroh@hanyang.ac.kr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hanyang USH</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roh Sungwon</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>July 30, 2020</last_update_submitted>
  <last_update_submitted_qc>July 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University Seoul Hospital</investigator_affiliation>
    <investigator_full_name>Sungwon Roh</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alcoholism</mesh_term>
    <mesh_term>Depressive Disorder</mesh_term>
    <mesh_term>Depression</mesh_term>
    <mesh_term>Alcohol Drinking</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>Acamprosate</mesh_term>
    <mesh_term>Vortioxetine</mesh_term>
  </intervention_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/NCT04498897
org study id: VTX-RCT
nct id: NCT04498897
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a randomized, double-blinded, placebo-controlled, multicenter study. A total of 128
      subjects will be randomly assigned to a test group or placebo group in a 1:1 ratio. Subjects
      will receive vortioxetine (or placebo) and acamprosate for 6 weeks according to the treatment
      group. Four visits will be made (weeks 0, 2, 4, 8), and on visit 2-4 (weeks 2, 4, 8)
      compliance, depression symptoms, and alcohol craving will be assessed.
Investigational product

        -  baseline: Vortioxetine 10mg (or placebo) qd + Acamprosate*

        -  First 2 weeks: Vortioxetine 5-10mg (or placebo) qd+ Acamprosate*

        -  Last 6 weeks: Vortioxetine 5-20mg (or placebo) qd + Acamprosate*

             -  Acamprosate 666 mg bid for bodyweight < 60 kg; Acamprosate 666 mg tid for
                bodyweight ≥ 60 kg
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized, placebo-controlled study
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: Double-blinded study
measure: K-MADRS
time frame: From baseline for 8 weeks
description: Korean-Version of the Montgomery-Asberg Depression Rating Scale
measure: OCDS-K
time frame: from baseline for 8 weeks
description: Korean version of the Obsessive Compulsive Drinking Scale
arm group label: Test group
arm group type: Active Comparator
description: Vortioxetine + Acamprosate
arm group label: Placebo Group
arm group type: Placebo Comparator
description: Placebo + Acamprosate
intervention type: Drug
intervention name: Vortioxetine
description: Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
arm group label: Test group
intervention type: Drug
intervention name: Acamprosate
description: Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate
arm group label: Placebo Group
arm group label: Test group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Sungwon Roh
role: Principal Investigator
affiliation: swroh@hanyang.ac.kr
last name: Ji-eun Kim
phone: 82-2-2290-8422
email: eva.jieun.kim@gmail.com
last name: Sungwon Roh
phone: 82-2-2290-8422
email: swroh@hanyang.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hanyang University Seoul Hospital
investigator full name: Sungwon Roh
investigator title: Professor
mesh term: Alcoholism
mesh term: Depressive Disorder
mesh term: Depression
mesh term: Alcohol Drinking
mesh term: Depressive Disorder, Major
mesh term: Acamprosate
mesh term: Vortioxetine