<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/NCT03788811</url>
  </required_header>
  <id_info>
    <org_study_id>dM/CL-01</org_study_id>
    <nct_id>NCT03788811</nct_id>
  </id_info>
  <brief_title>ERG Components in Schizophrenia and Bipolar Disorder Type I</brief_title>
  <official_title>Assessment of ERG Components to Discriminate Between Schizophrenia and Bipolar Disorder Type I</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>diaMentis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>diaMentis 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will further assess ERG components obtained with different ERG devices, to be&#xD;
      considered in a prediction model for each diagnosis. The prediction models are diaMentis&#xD;
      proprietary software used as an ERG-based diagnostic test (classified as a Software as&#xD;
      Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I.&#xD;
      They involve the processing and analysis of specific retinal biosignatures (RSPA) with the&#xD;
      support of statistical and mathematical modelling processes e.g. machine learning and&#xD;
      statistical learning.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The technology under development by diaMentis is defined as a Software as a Medical Device&#xD;
      (SaMD); it will be used in combination with an electroretinogram (ERG). This study will be&#xD;
      performed using three different ERG devices, currently marketed and cleared by the health&#xD;
      authorities (Espion, UTAS and RETeval) to support the analytical, scientific and performance&#xD;
      validity of the SaMD.&#xD;
&#xD;
      Anomalies detected by ERG provide an objective measure that may reflect specific underlying&#xD;
      dysfunctions in patients and thus hold promise to confirm relevant biosignatures in&#xD;
      psychiatric disorders. Significant differences between patients with SZ, BPI and control&#xD;
      subjects have been found despite confounding factors; this trial is required to better define&#xD;
      the impact of patient characteristics on ERG features with a potential to refine the&#xD;
      interpretation of results.&#xD;
&#xD;
      This is a multicenter study. Three hundred subjects will be enrolled into three groups: 100&#xD;
      SZ patients, 100 BPI patients and 100 control subjects (healthy volunteers).&#xD;
&#xD;
      The primary objective is to further characterize the ERG components in SZ and BPI patients in&#xD;
      order to develop prediction models that discriminate each pathology.&#xD;
&#xD;
      The secondary objectives are the evaluation of the repeatability and reproducibility of the&#xD;
      analysis of the ERG components in control subjects, the assessment of the reliability of ERG&#xD;
      prediction score for patients following a repeat test, and the evaluation of the impact of&#xD;
      different ERG devices on the data generated and the prediction models.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 5, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Differences in ERG components vs control ERG with full-field ERG stimulation conditions.</measure>
    <time_frame>Three ERG assessments within 6 weeks.</time_frame>
    <description>ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 100 msec post stimulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.</measure>
    <time_frame>Three ERG assessments within 6 weeks.</time_frame>
    <description>ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 250 msec post stimulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.</measure>
    <time_frame>Three ERG assessments within 6 weeks.</time_frame>
    <description>ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 300 msec post stimulation.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Schizophrenia</condition>
  <condition>Bipolar I Disorder</condition>
  <arm_group>
    <arm_group_label>Control subjects</arm_group_label>
    <description>Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with schizophrenia (SZ)</arm_group_label>
    <description>Patient with a diagnosis of schizophrenia for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Patients with bipolar disorder Type I (BP1)</arm_group_label>
    <description>Patient with a diagnosis of bipolar disorder Type 1 for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ERG assessment (RSPA)</intervention_name>
    <description>Processing and analysis of retinal signals</description>
    <arm_group_label>Control subjects</arm_group_label>
    <arm_group_label>Patients with bipolar disorder Type I (BP1)</arm_group_label>
    <arm_group_label>Patients with schizophrenia (SZ)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in a&#xD;
        diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT); and&#xD;
        control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder,&#xD;
        recurrent mood disorder or have not met criteria for a major depression episode in the last&#xD;
        12 months according to DSM-V criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Able to give written informed consent;&#xD;
&#xD;
          -  18 to 50 years old;&#xD;
&#xD;
          -  Patient with a likely diagnosis of SZ or BPI for at least 12 months, that resulted in&#xD;
             a diagnosis of SZ or BPI with a Structured Clinical Interview for DSM-5 (SCID-5-CT);&#xD;
&#xD;
          -  Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic&#xD;
             disorder, recurrent mood disorder or have not met criteria for a major depression&#xD;
             episode in the last 12 months according to DSM-V criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Control subjects taking antipsychotic drugs (other prescription medicines are&#xD;
             allowed);&#xD;
&#xD;
          -  Control subjects with a first-degree relative with SZ, BP, other psychotic disorder or&#xD;
             recurrent major depressive disorder;&#xD;
&#xD;
          -  Patient currently in an acute inpatient unit and not stable (i.e. experiencing an&#xD;
             acute exacerbation of psychosis or mania);&#xD;
&#xD;
          -  Diagnosed dementia, Parkinson's disease, autism or other pervasive developmental&#xD;
             disorders or seizure disorders (such as epilepsy);&#xD;
&#xD;
          -  Substance use disorder within the last 6 months;&#xD;
&#xD;
          -  Any known diagnosis of ophthalmological abnormalities, such as diabetic retinopathy,&#xD;
             glaucoma, change in intraocular pressure, macular degeneration, other retinal&#xD;
             pathologies, congenital color vision deficiencies, strabismus or cataract;&#xD;
&#xD;
          -  Any person contra-indicated for an ERG test, including active corneal or conjunctival&#xD;
             disease (e.g. pink eye or conjunctivitis), infection or a ruptured globe;&#xD;
&#xD;
          -  Subjects in recovery phase following cataract surgery or post LASIK refractive surgery&#xD;
             or trabeculectomy or any surgical/laser intervention, suspected penetrating ocular&#xD;
             injury, ocular prosthesis or severe photophobia;&#xD;
&#xD;
          -  Any person unable to or unwilling to participate in a psychiatric evaluation or ERG&#xD;
             testing, including, in the clinical judgment of the Principal investigator, subjects&#xD;
             with cognitive impairment that compromises their ability to participate meaningfully&#xD;
             in a SCID-5-CT interview.&#xD;
&#xD;
          -  Any subject during the course of the study that is pregnant or intends on becoming&#xD;
             pregnant and/or receives or intends to receive fertility treatments. Subjects becoming&#xD;
             pregnant during study will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claude Hariton, PhD, DSc</last_name>
    <role>Study Director</role>
    <affiliation>diaMentis Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research LLC</name>
      <address>
        <city>Garden Grove</city>
        <state>California</state>
        <zip>92845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Synergy San Diego</name>
      <address>
        <city>Lemon Grove</city>
        <state>California</state>
        <zip>91945</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Collaborative Neuroscience Research LLC</name>
      <address>
        <city>Torrance</city>
        <state>California</state>
        <zip>90502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Segal trials West Broward Outpatient Site</name>
      <address>
        <city>Lauderhill</city>
        <state>Florida</state>
        <zip>33319</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Segal Trials Miami Lakes Medical Research</name>
      <address>
        <city>Miami Lakes</city>
        <state>Florida</state>
        <zip>33016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McLean Hospital</name>
      <address>
        <city>Belmont</city>
        <state>Massachusetts</state>
        <zip>02478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rutgers University Behavioral HealthCare</name>
      <address>
        <city>Piscataway</city>
        <state>New Jersey</state>
        <zip>08854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Zucker Hillside Hospital</name>
      <address>
        <city>Glen Oaks</city>
        <state>New York</state>
        <zip>11004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Rochester Medical Center</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Richmond Behavioral Associates</name>
      <address>
        <city>Staten Island</city>
        <state>New York</state>
        <zip>10314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hills Clinical Research</name>
      <address>
        <city>Irving</city>
        <state>Texas</state>
        <zip>75062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barwon Health University Hospital</name>
      <address>
        <city>Geelong</city>
        <state>Victoria</state>
        <zip>3220</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albert Road Clinic</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3004</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen's University</name>
      <address>
        <city>Kingston</city>
        <state>Ontario</state>
        <zip>K7L 3N6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre for Addiction and Mental Health (CAMH)</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M6J 1H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire en Santé Mentale de Montréal</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H1N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Douglas Mental Health University Institute</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4H 1R3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CISSS-CA Hôpital de Saint-Georges</name>
      <address>
        <city>Saint-Georges</city>
        <state>Quebec</state>
        <zip>G5Y 4T8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 24, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 28, 2018</study_first_posted>
  <last_update_submitted>April 5, 2023</last_update_submitted>
  <last_update_submitted_qc>April 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Retinal Signal</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>Bipolar I Disorder</keyword>
  <keyword>Support to diagnostic</keyword>
  <keyword>ERG</keyword>
  <keyword>Mental Disorder</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03788811
org study id: dM/CL-01
nct id: NCT03788811
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
This study will further assess ERG components obtained with different ERG devices, to be
      considered in a prediction model for each diagnosis. The prediction models are diaMentis
      proprietary software used as an ERG-based diagnostic test (classified as a Software as
      Medical Device, SaMD) to support the diagnosis of schizophrenia and bipolar disorder type I.
      They involve the processing and analysis of specific retinal biosignatures (RSPA) with the
      support of statistical and mathematical modelling processes e.g. machine learning and
      statistical learning.
The technology under development by diaMentis is defined as a Software as a Medical Device
      (SaMD); it will be used in combination with an electroretinogram (ERG). This study will be
      performed using three different ERG devices, currently marketed and cleared by the health
      authorities (Espion, UTAS and RETeval) to support the analytical, scientific and performance
      validity of the SaMD.

      Anomalies detected by ERG provide an objective measure that may reflect specific underlying
      dysfunctions in patients and thus hold promise to confirm relevant biosignatures in
      psychiatric disorders. Significant differences between patients with SZ, BPI and control
      subjects have been found despite confounding factors; this trial is required to better define
      the impact of patient characteristics on ERG features with a potential to refine the
      interpretation of results.

      This is a multicenter study. Three hundred subjects will be enrolled into three groups: 100
      SZ patients, 100 BPI patients and 100 control subjects (healthy volunteers).

      The primary objective is to further characterize the ERG components in SZ and BPI patients in
      order to develop prediction models that discriminate each pathology.

      The secondary objectives are the evaluation of the repeatability and reproducibility of the
      analysis of the ERG components in control subjects, the assessment of the reliability of ERG
      prediction score for patients following a repeat test, and the evaluation of the impact of
      different ERG devices on the data generated and the prediction models.
observational model: Case-Control
time perspective: Prospective
measure: Differences in ERG components vs control ERG with full-field ERG stimulation conditions.
time frame: Three ERG assessments within 6 weeks.
description: ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 100 msec post stimulation.
measure: Differences in ERG components vs control ERG with Photopic Negative Response (PhNR) ERG stimulation conditions.
time frame: Three ERG assessments within 6 weeks.
description: ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 250 msec post stimulation.
measure: Differences in ERG components vs control ERG with On-Off ERG stimulation conditions.
time frame: Three ERG assessments within 6 weeks.
description: ERG components are retinal signal features (signal amplitude vs time) in the electrical signal recorded up to 300 msec post stimulation.
arm group label: Control subjects
description: Control subjects who do not have a lifetime diagnosis of SZ, BP, other psychotic disorder, recurrent mood disorder or have not met criteria for a major depression episode in the last 12 months according to DSM-V criteria.
arm group label: Patients with schizophrenia (SZ)
description: Patient with a diagnosis of schizophrenia for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).
arm group label: Patients with bipolar disorder Type I (BP1)
description: Patient with a diagnosis of bipolar disorder Type 1 for at least 12 months, that resulted in a diagnosis with a Structured Clinical Interview for DSM-5 (SCID-5-CT).
intervention type: Device
intervention name: ERG assessment (RSPA)
description: Processing and analysis of retinal signals
arm group label: Control subjects
arm group label: Patients with bipolar disorder Type I (BP1)
arm group label: Patients with schizophrenia (SZ)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claude Hariton, PhD, DSc
role: Study Director
affiliation: diaMentis Inc.
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country: Australia
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Schizophrenia
mesh term: Bipolar Disorder
sharing ipd: No