<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/NCT01712321</url>
  </required_header>
  <id_info>
    <org_study_id>VII-IT-07</org_study_id>
    <nct_id>NCT01712321</nct_id>
  </id_info>
  <brief_title>Study of Vilazodone to Treat Social Anxiety Disorder</brief_title>
  <official_title>Vilazodone in the Treatment of Social Anxiety Disorder: A Double Blind Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Medical Research Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Forest Laboratories</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>The Medical Research Network</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether Vilazodone is effective in the treatment of&#xD;
      symptoms of Social Anxiety Disorder among adults.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses&#xD;
      of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The&#xD;
      study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at&#xD;
      least one post randomization visit where efficacy evaluations are conducted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">April 2014</completion_date>
  <primary_completion_date type="Anticipated">March 2014</primary_completion_date>
  <phase>N/A</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Liebowitz Social Anxiety Scale (LSAS) - total score</measure>
    <time_frame>Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks</time_frame>
    <description>All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2</measure>
    <time_frame>Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Responder rate as defined by a CGI Improvement score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.&#xD;
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the Clinical Global Impression of Severity of Illness score</measure>
    <time_frame>Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change on the LSAS anxiety and avoidance subscales</measure>
    <time_frame>Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hamilton Depression scale total</measure>
    <time_frame>Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Hamilton Anxiety scale total</measure>
    <time_frame>Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Subject-assessed responder rate</measure>
    <time_frame>Study Endpoint: minimum 6 weeks - maximum 12 weeks</time_frame>
    <description>Subject-assessed responder rate, as defined by a Patient Global Impression of Change score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.&#xD;
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Social Anxiety Disorder</condition>
  <arm_group>
    <arm_group_label>Vilazodone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vilazodone</intervention_name>
    <description>Vilazodone 20mg or 40mg taken once daily by mouth</description>
    <arm_group_label>Vilazodone</arm_group_label>
    <other_name>Viibryd</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Matching placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of Social Anxiety Disorder, generalized subtype&#xD;
&#xD;
          -  LSAS total score of 70 at visits 1 and 2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lifetime history of Bipolar disorder or Schizophrenia&#xD;
&#xD;
          -  Current suicidal risk&#xD;
&#xD;
          -  Current unstable medical condition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael R. Liebowitz, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Medical Research Network, LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Medical Research Network, LLC</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2014</verification_date>
  <study_first_submitted>October 18, 2012</study_first_submitted>
  <study_first_submitted_qc>October 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 23, 2012</study_first_posted>
  <last_update_submitted>January 16, 2014</last_update_submitted>
  <last_update_submitted_qc>January 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 20, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Social Anxiety Disorder</keyword>
  <keyword>Social Anxiety</keyword>
  <keyword>Social Phobia</keyword>
  <keyword>SAD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anxiety Disorders</mesh_term>
    <mesh_term>Phobia, Social</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vilazodone Hydrochloride</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>August 25, 2016</submitted>
    <returned>October 19, 2016</returned>
  </pending_results>
  <!-- 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/NCT01712321
org study id: VII-IT-07
nct id: NCT01712321
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to determine whether Vilazodone is effective in the treatment of
      symptoms of Social Anxiety Disorder among adults.
The proposed study is a 12 week double-blind, placebo-controlled trial in which daily doses
      of vilazodone 20 to 40 mg/day or matching placebo will be administered on a 1:1 ratio. The
      study will include 30 outpatients age 18-75 with SAD, generalized subtype who return for at
      least one post randomization visit where efficacy evaluations are conducted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Change in Liebowitz Social Anxiety Scale (LSAS) - total score
time frame: Change from Baseline to Final Study Visit: minimum 1 week - maximum 12 weeks
description: All subjects randomized to drug or placebo and returning for at least one subsequent visit will be included in the primary efficacy analyses.
measure: Responder rate, as defined by Clinical Global Impression of Improvement score of 1 or 2
time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Responder rate as defined by a CGI Improvement score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
measure: Change in the Clinical Global Impression of Severity of Illness score
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
measure: Change on the LSAS anxiety and avoidance subscales
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
measure: Change in Hamilton Depression scale total
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
measure: Change in Hamilton Anxiety scale total
time frame: Change from Baseline to Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
measure: Subject-assessed responder rate
time frame: Study Endpoint: minimum 6 weeks - maximum 12 weeks
description: Subject-assessed responder rate, as defined by a Patient Global Impression of Change score of 1 (Very Much Improved) or 2 (Much Improved) at study endpoint.
Randomized subjects taking minimum target dose (20mg or matching placebo daily) for at least six consecutive weeks will be considered a minimum adequate trial for the purposes of secondary analyses.
arm group label: Vilazodone
arm group type: Experimental
description: Vilazodone 20mg or 40mg taken once daily by mouth for up to 12 weeks
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo to match Vilazodone 20mg or 40mg, taken once daily by mouth for up to 12 weeks
intervention type: Drug
intervention name: Vilazodone
description: Vilazodone 20mg or 40mg taken once daily by mouth
arm group label: Vilazodone
other name: Viibryd
intervention type: Drug
intervention name: Placebo
description: Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
arm group label: Placebo
other name: Matching placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Michael R. Liebowitz, MD
role: Principal Investigator
affiliation: The Medical Research Network, LLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Anxiety Disorders
mesh term: Phobia, Social
mesh term: Vilazodone Hydrochloride
submitted: August 25, 2016
returned: October 19, 2016