xml: <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/NCT06037668</url>
    </required_header>
    <id_info>
      <org_study_id>BVR-100-102</org_study_id>
      <nct_id>NCT06037668</nct_id>
    </id_info>
    <brief_title>A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.</brief_title>
    <acronym>BVR-100-102</acronym>
    <official_title>BVR-100 and BES-100 Validation Trial: A Randomized, Double-Blind, Parallel-Group, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Sumitomo Pharma America, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>BehaVR LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Sumitomo Pharma America, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100,&#xD;
        for the treatment of Social Anxiety Disorder (SAD).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">January 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">January 31, 2024</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>The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores</measure>
      <time_frame>baseline, week 6, week 8 (EOS)</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>subject retention of BVR-100 and BES-100</measure>
      <time_frame>week 6, week 8 (EOS)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>time-on-task of BVR-100 and BES-100</measure>
      <time_frame>week 6, week 8 (EOS)</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Social Anxiety Disorder (SAD)</condition>
    <arm_group>
      <arm_group_label>BVR-100</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Experimental at-home VR intervention for the treatment of SAD</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BES-100</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Active at-home VR intervention comparator</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BVR-100</intervention_name>
      <description>Experimental self-guided VR intervention for the treatment of SAD</description>
      <arm_group_label>BVR-100</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>BES-100</intervention_name>
      <description>Active at-home VR intervention comparator</description>
      <arm_group_label>BES-100</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subject is male or female, aged 18 or above.&#xD;
  &#xD;
            -  Subject has English fluency and literacy.&#xD;
  &#xD;
            -  Subject meets the Diagnostic and Statistical Manual of Mental Disorders, Fifth&#xD;
               Edition, (DSM-5) criteria for Social Anxiety Disorder&#xD;
  &#xD;
            -  Subject has a total Liebowitz Social Anxiety Scale (LSAS) score at Screening of ≥ 70.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Subject has significant visual, auditory or balance impairment&#xD;
  &#xD;
            -  Subject has history of photosensitive epilepsy or seizure disorder&#xD;
  &#xD;
            -  Subject has history of motion sickness or medical condition predisposing to nausea or&#xD;
               dizziness.&#xD;
  &#xD;
            -  Subject has injuries, inflammation or infection affecting the eyes, ears or face that&#xD;
               would make the use of the hardware uncomfortable.&#xD;
  &#xD;
            -  Subject has, current or lifetime history of meeting DSM-5 criteria for schizophrenia&#xD;
               spectrum or other psychotic disorder, bipolar or related disorder, major&#xD;
               neurocognitive disorder, neurodevelopmental disorder of greater than mild severity or&#xD;
               of a severity that impacts the subject's ability to consent, follow study directions,&#xD;
               or otherwise safely participate in the study; posttraumatic stress disorder, major&#xD;
               depressive disorder (MDD) with psychotic features, borderline or antisocial&#xD;
               personality disorder&#xD;
  &#xD;
            -  Subject has met DSM-5-based criteria for Alcohol or Substance Use Disorder (other than&#xD;
               nicotine or caffeine) within one (1) year prior to Screening.&#xD;
  &#xD;
            -  Subject has received ketamine, esketamine, arketamine, or psychedelic therapies (eg,&#xD;
               psilocybin, methylenedioxymethamphetamine [MDMA]) for MDD or any psychiatric condition&#xD;
               within one (1) year prior to Screening.&#xD;
  &#xD;
            -  In the opinion of the Investigator: (a) study participation may pose a significant or&#xD;
               undue risk to the subject; (b) the subject is unlikely to successfully complete all of&#xD;
               the requirements of the study per protocol; or (c) study participation may adversely&#xD;
               impact the integrity of the data or the validity of the study results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>99 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Robert Hayes, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Sumitomo Pharma America, Inc.</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Clinical Trial Disclosure</last_name>
      <phone>1-866-503-6351</phone>
      <email>clinicaltrialdisclosure@sunovion.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Social Anxiety Disorder, Social Phobia</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>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037668
  org study id: BVR-100-102
  nct id: NCT06037668
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: No
  This study is to compare two Virtual Reality (VR)-based interventions, BVR-100 and BES-100,
        for the treatment of Social Anxiety Disorder (SAD).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: The measurement of intervention credibility and expectancy of benefit, assessed with the Credibility / Expectancy Questionnaire (CEQ) scores
  time frame: baseline, week 6, week 8 (EOS)
  measure: subject retention of BVR-100 and BES-100
  time frame: week 6, week 8 (EOS)
  measure: time-on-task of BVR-100 and BES-100
  time frame: week 6, week 8 (EOS)
  arm group label: BVR-100
  arm group type: Experimental
  description: Experimental at-home VR intervention for the treatment of SAD
  arm group label: BES-100
  arm group type: Active Comparator
  description: Active at-home VR intervention comparator
  intervention type: Device
  intervention name: BVR-100
  description: Experimental self-guided VR intervention for the treatment of SAD
  arm group label: BVR-100
  intervention type: Device
  intervention name: BES-100
  description: Active at-home VR intervention comparator
  arm group label: BES-100
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 99 Years
  healthy volunteers: No
  last name: Robert Hayes, PhD
  role: Study Director
  affiliation: Sumitomo Pharma America, Inc.
  last name: Clinical Trial Disclosure
  phone: 1-866-503-6351
  email: clinicaltrialdisclosure@sunovion.com
  responsible party type: Sponsor
  mesh term: Anxiety Disorders
  mesh term: Phobia, Social