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/NCT06011408</url>
    </required_header>
    <id_info>
      <org_study_id>#23-002</org_study_id>
      <secondary_id>R43MH114763</secondary_id>
      <nct_id>NCT06011408</nct_id>
    </id_info>
    <brief_title>Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes</brief_title>
    <official_title>Remote Monitoring and Detecting of Tardive Dyskinesia for Improving Patient Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>iRxReminder</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Mental Health (NIMH)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>iRxReminder</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study is being conducted to validate the feasibility of remote assessment of Tardive&#xD;
        Dyskinesia.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study is being conducted to validate the feasibility of remote assessment of Tardive&#xD;
        Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a&#xD;
        diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview&#xD;
        questions and elements of the Abnormal Involuntary Movement Scale will be collected on video.&#xD;
        The videos will be rated by trained observers. Machine learning methods will be used to&#xD;
        develop an algorithm to detect abnormal movements in individuals with a known Tardive&#xD;
        Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to&#xD;
        determine the accuracy of the algorithm.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 30, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>AIMS Score</measure>
      <time_frame>Baseline</time_frame>
      <description>Abnormal Involuntary Scale Score</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">300</enrollment>
    <condition>Tardive Dyskinesia</condition>
    <arm_group>
      <arm_group_label>Taking antipsychotic medication with Tardive Dyskinesia</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Taking antipsychotic medication without Tardive Dyskinesia</arm_group_label>
      <arm_group_type>Other</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>TDtect</intervention_name>
      <description>Collecting video data on abnormal movement</description>
      <arm_group_label>Taking antipsychotic medication with Tardive Dyskinesia</arm_group_label>
      <arm_group_label>Taking antipsychotic medication without Tardive Dyskinesia</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          For the non-TD group:&#xD;
  &#xD;
            1. Prescribed and taking an antipsychotic medication for 90-days or longer.&#xD;
  &#xD;
            2. Tardive Dyskinesia symptoms if present are not from Parkinsons, Tourette's syndrome,&#xD;
               Huntington disease.&#xD;
  &#xD;
            3. Signed an informed consent.&#xD;
  &#xD;
            4. Speaks English fluently.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Suffered a moderate or severe head injury in the last year;&#xD;
  &#xD;
            2. History of a learning disorder or developmental disability that would inhibit a&#xD;
               patient from completing the TD protocol.&#xD;
  &#xD;
            3. Severe visual impairment that is cannot be corrected by glasses or contacts.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rakesh Ranjan, M.D.</last_name>
      <role>Study Director</role>
      <affiliation>Charak Research Center</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Owen Muir, M.D.</last_name>
      <role>Study Director</role>
      <affiliation>Fermata Health</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Anthony Sterns, Ph.D.</last_name>
      <phone>3306066675</phone>
      <email>asterns@irxreminder.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Fred Ma, M.D., Ph.D.</last_name>
      <phone>2164695725</phone>
      <email>fma@irxreminder.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Fermata Helath</name>
        <address>
          <city>Brooklyn</city>
          <state>New York</state>
          <zip>10038</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Nogga Schwartz</last_name>
        <phone>201-951-0881</phone>
        <email>nogga.schwartz@fermata.health</email>
      </contact>
      <investigator>
        <last_name>Owen Muir, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location>
      <facility>
        <name>Charak Research Center</name>
        <address>
          <city>Garfield Heights</city>
          <state>Ohio</state>
          <zip>44125</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Kenzie Miller</last_name>
        <phone>216-280-6374</phone>
        <email>kmiller@atcharakcenter.com</email>
      </contact>
      <investigator>
        <last_name>Rakesh Ranjan, M.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://www.irxreminder.com</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>http://www.charakcenter.com</url>
      <description>Related Info</description>
    </link>
    <link>
      <url>http://www.fermata.health</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dyskinesias</mesh_term>
      <mesh_term>Tardive Dyskinesia</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/NCT06011408
  org study id: #23-002
  secondary id: R43MH114763
  nct id: NCT06011408
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The study is being conducted to validate the feasibility of remote assessment of Tardive
        Dyskinesia.
  The study is being conducted to validate the feasibility of remote assessment of Tardive
        Dyskinesia. Participants will all be taking an antipsychotic medication and half will have a
        diagnosis of Tardive Dyskinesia and half will not. Participant responses to interview
        questions and elements of the Abnormal Involuntary Movement Scale will be collected on video.
        The videos will be rated by trained observers. Machine learning methods will be used to
        develop an algorithm to detect abnormal movements in individuals with a known Tardive
        Dyskinesia diagnosis. The trained rater results will be compared to the algorithm to
        determine the accuracy of the algorithm.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: Open-label, observational study with two groups taking antipsychotic with or without Tardive Dyskinesia
  primary purpose: Screening
  masking: None (Open Label)
  measure: AIMS Score
  time frame: Baseline
  description: Abnormal Involuntary Scale Score
  arm group label: Taking antipsychotic medication with Tardive Dyskinesia
  arm group type: Other
  arm group label: Taking antipsychotic medication without Tardive Dyskinesia
  arm group type: Other
  intervention type: Other
  intervention name: TDtect
  description: Collecting video data on abnormal movement
  arm group label: Taking antipsychotic medication with Tardive Dyskinesia
  arm group label: Taking antipsychotic medication without Tardive Dyskinesia
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Rakesh Ranjan, M.D.
  role: Study Director
  affiliation: Charak Research Center
  last name: Owen Muir, M.D.
  role: Study Director
  affiliation: Fermata Health
  last name: Anthony Sterns, Ph.D.
  phone: 3306066675
  email: asterns@irxreminder.com
  last name: Fred Ma, M.D., Ph.D.
  phone: 2164695725
  email: fma@irxreminder.com
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United States
  url: http://www.irxreminder.com
  description: Related Info
  url: http://www.charakcenter.com
  description: Related Info
  url: http://www.fermata.health
  description: Related Info
  responsible party type: Sponsor
  mesh term: Dyskinesias
  mesh term: Tardive Dyskinesia