<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/NCT04444180</url>
  </required_header>
  <id_info>
    <org_study_id>CRC2018YB01</org_study_id>
    <nct_id>NCT04444180</nct_id>
  </id_info>
  <brief_title>The Predictive Role of Self-representation in Transition of Individuals at Clinical High Risk for Psychosis</brief_title>
  <official_title>The Predictive Role of Self Representation in Transition of Individuals at Clinical High Risk for Psychosis -- a Study on the Clinical Application of Virtual Hand Illusion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</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>
      Schizophrenia is one of the most consumptive diseases, which brings great loss to patients&#xD;
      and their families, and even to the society. Clinical High Risk for Psychosis (CHR) is a&#xD;
      concept put forward on the basis of the prodromal stage of schizophrenia. Over the past 20&#xD;
      years, the identification and intervention of CHR has become the focus of psychiatric&#xD;
      research, with the primary goal of early identification of biomarkers of susceptibility to&#xD;
      schizophrenia and the development of individualized interventions to prevent or delay&#xD;
      progression. Longitudinal studies have shown that CHR converted to schizophrenia mainly&#xD;
      within two years, with a risk of about 30 percent. Self-disorder is one of the core&#xD;
      characteristics of schizophrenia. The two most basic experiences of self-representation are&#xD;
      sense of ownership and sense of agency. Sense of ownership refers to the sense that &quot;I&quot;&#xD;
      perceives &quot;my&quot; body, while sense of agency refers to the sense that &quot;I&quot; experiences &quot;my&quot;&#xD;
      actions and their consequences are initiated by &quot;me&quot;. Some studies have shown that patients&#xD;
      with schizophrenia show defects in the sense of ownership and agency. The most commonly used&#xD;
      paradigm for observing &quot;sense of ownership&quot; and &quot;sense of agency&quot; is the rubber hand illusion&#xD;
      (RHI) or the virtual hand illusion (VHI). In this study, the VHI experimental paradigm will&#xD;
      be used to detect the self-representation of the individuals at high risk for psychosis, and&#xD;
      the clinical outcome will be observed for one year.The hypothesis is that the subjects who&#xD;
      exhibit abnormal illusion experience in VHI experiment are more likely to transition into&#xD;
      psychotic disorders.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is conducted according to the tenets of the Declaration of Helsinki. All&#xD;
      participants are recruited at the Shanghai Mental Health Center (SMHC) or its affiliate, the&#xD;
      Shanghai Psychotherapy and Psychological Counseling Center (SPCC) with written informed&#xD;
      consent, approved by the Research Ethics Committee of SMHC. For those younger than 18 years,&#xD;
      both the adolescents and their next of kin or legal guardians are provided informed consents.&#xD;
      The outpatients are recommended by doctors to participate in our CHR screening. After being&#xD;
      screened and interviewed, those who meet the inclusion criteria are informed and signed&#xD;
      written informed consent. Once the subjects are recruited, clinical evaluation, VHI and MCCB&#xD;
      test will be conducted. In addition, CHR individuals will be followed up at one-year node.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 6, 2019</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">November 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Behavioral indicators</measure>
    <time_frame>Baseline</time_frame>
    <description>To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Predictive indicators</measure>
    <time_frame>One-year follow-up node</time_frame>
    <description>To analyze the predictive role of self-representation in transition of CHR into psychosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Resting-state brain functional connectivity (FC)</measure>
    <time_frame>Baseline</time_frame>
    <description>To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-related potential technique</measure>
    <time_frame>Baseline</time_frame>
    <description>To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neurocognitive function</measure>
    <time_frame>Baseline</time_frame>
    <description>To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Other predictive indicators</measure>
    <time_frame>One-year follow-up node</time_frame>
    <description>To analyze the predictive role of FC and neurocognitive functions related to self-representation in transition of CHR into psychosis</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">160</enrollment>
  <condition>Clinical High Risk for Psychosis</condition>
  <arm_group>
    <arm_group_label>Clinical high risk for psychosis (CHR)</arm_group_label>
    <description>No intervention. Just use virtual hand illusion (VHI) paradigm to observe the outcome of individuals with CHR at one-year follow-up node and analyze the predictive role of self-representation in transition into psychosis.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First episode of schizophrenia (FES)</arm_group_label>
    <description>In contrast to FES, it is anticipated to observe CHR individuals with similar behavioral performance to FES may presented higher risk of transition.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy control (HC)</arm_group_label>
    <description>In contrast to HC, it is anticipated to observe CHR individuals with similar behavioral performance to HC may presented lower risk of transition.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Virtual hand illusion (VHI)</intervention_name>
    <description>Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.</description>
    <arm_group_label>Clinical high risk for psychosis (CHR)</arm_group_label>
    <arm_group_label>First episode of schizophrenia (FES)</arm_group_label>
    <arm_group_label>Healthy control (HC)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study mainly observe the behavioral representation and its predictive role in&#xD;
        transition outcome of CHR individuals, who meeting the criteria of psychosis-risk syndromes&#xD;
        (COPS) for the existence of one or more of psychosis high risk syndromes, such as brief&#xD;
        intermittent psychotic syndrome (BIPS), attenuated positive symptom syndrome (APSS), and&#xD;
        genetic risk and deterioration syndrome (DRDS).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For CHR individuals, meet the criteria of psychosis-risk syndromes after rating by&#xD;
             structured interview for psychosis high risk syndrome.&#xD;
&#xD;
          -  For FES patients, meet diagnostic criteria for schizophrenia in the DSM-IV.&#xD;
&#xD;
          -  For HC individuals, gender composition, age range, educational level are matched with&#xD;
             CHR individuals.&#xD;
&#xD;
          -  Understand and sign written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  For CHR individuals, exclude individuals with other axis I or II mental disorders,&#xD;
             which can explain the abnormal experience.&#xD;
&#xD;
          -  For CHR and FES patients, exclude those patients taking antipsychotics for more than&#xD;
             two weeks.&#xD;
&#xD;
          -  For HC individuals, exclude those with family history of mental disorders&#xD;
&#xD;
          -  With a history of substance dependence.&#xD;
&#xD;
          -  Use of medications that may affect mental and cognitive functions.&#xD;
&#xD;
          -  With central nervous system disorder, that cuase symptoms or interfere with judgment.&#xD;
&#xD;
          -  Traumatic brain injury score is 7 or more.&#xD;
&#xD;
          -  With serious or unstable physical diseases.&#xD;
&#xD;
          -  With perceptual developmental disorders.&#xD;
&#xD;
          -  IQ&lt;70.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>11 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jijun Wang, Doctoral</last_name>
    <role>Study Chair</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tianhong Zhang, Doctoral</last_name>
    <role>Study Director</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <results_reference>
    <citation>Raballo A, Monducci E, Ferrara M, Fiori Nastro P, Dario C; RODIN group. Developmental vulnerability to psychosis: Selective aggregation of basic self-disturbance in early onset schizophrenia. Schizophr Res. 2018 Nov;201:367-372. doi: 10.1016/j.schres.2018.05.012. Epub 2018 May 25.</citation>
    <PMID>29804931</PMID>
  </results_reference>
  <results_reference>
    <citation>Ebisch SJH, Aleman A. The fragmented self: imbalance between intrinsic and extrinsic self-networks in psychotic disorders. Lancet Psychiatry. 2016 Aug;3(8):784-790. doi: 10.1016/S2215-0366(16)00045-6. Epub 2016 Jun 30.</citation>
    <PMID>27374147</PMID>
  </results_reference>
  <results_reference>
    <citation>Newen A, Vogeley K. Self-representation: searching for a neural signature of self-consciousness. Conscious Cogn. 2003 Dec;12(4):529-43. doi: 10.1016/s1053-8100(03)00080-1.</citation>
    <PMID>14656496</PMID>
  </results_reference>
  <results_reference>
    <citation>Synofzik M, Vosgerau G, Newen A. I move, therefore I am: a new theoretical framework to investigate agency and ownership. Conscious Cogn. 2008 Jun;17(2):411-24. doi: 10.1016/j.concog.2008.03.008. Epub 2008 Apr 14.</citation>
    <PMID>18411059</PMID>
  </results_reference>
  <results_reference>
    <citation>Shaqiri A, Roinishvili M, Kaliuzhna M, Favrod O, Chkonia E, Herzog MH, Blanke O, Salomon R. Rethinking Body Ownership in Schizophrenia: Experimental and Meta-analytical Approaches Show no Evidence for Deficits. Schizophr Bull. 2018 Apr 6;44(3):643-652. doi: 10.1093/schbul/sbx098.</citation>
    <PMID>29036731</PMID>
  </results_reference>
  <results_reference>
    <citation>Germine L, Benson TL, Cohen F, Hooker CI. Psychosis-proneness and the rubber hand illusion of body ownership. Psychiatry Res. 2013 May 15;207(1-2):45-52. doi: 10.1016/j.psychres.2012.11.022. Epub 2012 Dec 28.</citation>
    <PMID>23273611</PMID>
  </results_reference>
  <results_reference>
    <citation>Fusar-Poli P, Cappucciati M, Borgwardt S, Woods SW, Addington J, Nelson B, Nieman DH, Stahl DR, Rutigliano G, Riecher-Rossler A, Simon AE, Mizuno M, Lee TY, Kwon JS, Lam MM, Perez J, Keri S, Amminger P, Metzler S, Kawohl W, Rossler W, Lee J, Labad J, Ziermans T, An SK, Liu CC, Woodberry KA, Braham A, Corcoran C, McGorry P, Yung AR, McGuire PK. Heterogeneity of Psychosis Risk Within Individuals at Clinical High Risk: A Meta-analytical Stratification. JAMA Psychiatry. 2016 Feb;73(2):113-20. doi: 10.1001/jamapsychiatry.2015.2324.</citation>
    <PMID>26719911</PMID>
  </results_reference>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>January 19, 2023</last_update_submitted>
  <last_update_submitted_qc>January 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>sense of ownership</keyword>
  <keyword>sense of agency</keyword>
  <keyword>virtual hand illusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Psychotic Disorders</mesh_term>
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04444180
org study id: CRC2018YB01
nct id: NCT04444180
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Schizophrenia is one of the most consumptive diseases, which brings great loss to patients
      and their families, and even to the society. Clinical High Risk for Psychosis (CHR) is a
      concept put forward on the basis of the prodromal stage of schizophrenia. Over the past 20
      years, the identification and intervention of CHR has become the focus of psychiatric
      research, with the primary goal of early identification of biomarkers of susceptibility to
      schizophrenia and the development of individualized interventions to prevent or delay
      progression. Longitudinal studies have shown that CHR converted to schizophrenia mainly
      within two years, with a risk of about 30 percent. Self-disorder is one of the core
      characteristics of schizophrenia. The two most basic experiences of self-representation are
      sense of ownership and sense of agency. Sense of ownership refers to the sense that "I"
      perceives "my" body, while sense of agency refers to the sense that "I" experiences "my"
      actions and their consequences are initiated by "me". Some studies have shown that patients
      with schizophrenia show defects in the sense of ownership and agency. The most commonly used
      paradigm for observing "sense of ownership" and "sense of agency" is the rubber hand illusion
      (RHI) or the virtual hand illusion (VHI). In this study, the VHI experimental paradigm will
      be used to detect the self-representation of the individuals at high risk for psychosis, and
      the clinical outcome will be observed for one year.The hypothesis is that the subjects who
      exhibit abnormal illusion experience in VHI experiment are more likely to transition into
      psychotic disorders.
This study is conducted according to the tenets of the Declaration of Helsinki. All
      participants are recruited at the Shanghai Mental Health Center (SMHC) or its affiliate, the
      Shanghai Psychotherapy and Psychological Counseling Center (SPCC) with written informed
      consent, approved by the Research Ethics Committee of SMHC. For those younger than 18 years,
      both the adolescents and their next of kin or legal guardians are provided informed consents.
      The outpatients are recommended by doctors to participate in our CHR screening. After being
      screened and interviewed, those who meet the inclusion criteria are informed and signed
      written informed consent. Once the subjects are recruited, clinical evaluation, VHI and MCCB
      test will be conducted. In addition, CHR individuals will be followed up at one-year node.
observational model: Cohort
time perspective: Prospective
measure: Behavioral indicators
time frame: Baseline
description: To compare the behavioral performance in VHI experimental paradigm among the three groups of CHR, FES, and HC
measure: Predictive indicators
time frame: One-year follow-up node
description: To analyze the predictive role of self-representation in transition of CHR into psychosis
measure: Resting-state brain functional connectivity (FC)
time frame: Baseline
description: To observe the relationship of the behavioral performance in VHI experimental paradigm with the Resting-state brain functional connectivity
measure: Event-related potential technique
time frame: Baseline
description: To observe the relationship of the behavioral performance in VHI experimental paradigm with the error-related negativity
measure: Neurocognitive function
time frame: Baseline
description: To observe the relationship of the behavioral performance in VHI experimental paradigm with the neurocognitive functions
measure: Other predictive indicators
time frame: One-year follow-up node
description: To analyze the predictive role of FC and neurocognitive functions related to self-representation in transition of CHR into psychosis
arm group label: Clinical high risk for psychosis (CHR)
description: No intervention. Just use virtual hand illusion (VHI) paradigm to observe the outcome of individuals with CHR at one-year follow-up node and analyze the predictive role of self-representation in transition into psychosis.
arm group label: First episode of schizophrenia (FES)
description: In contrast to FES, it is anticipated to observe CHR individuals with similar behavioral performance to FES may presented higher risk of transition.
arm group label: Healthy control (HC)
description: In contrast to HC, it is anticipated to observe CHR individuals with similar behavioral performance to HC may presented lower risk of transition.
intervention type: Diagnostic Test
intervention name: Virtual hand illusion (VHI)
description: Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.
arm group label: Clinical high risk for psychosis (CHR)
arm group label: First episode of schizophrenia (FES)
arm group label: Healthy control (HC)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 11 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jijun Wang, Doctoral
role: Study Chair
affiliation: Shanghai Mental Health Center
last name: Tianhong Zhang, Doctoral
role: Study Director
affiliation: Shanghai Mental Health Center
facility: 
country: China
citation: Raballo A, Monducci E, Ferrara M, Fiori Nastro P, Dario C; RODIN group. Developmental vulnerability to psychosis: Selective aggregation of basic self-disturbance in early onset schizophrenia. Schizophr Res. 2018 Nov;201:367-372. doi: 10.1016/j.schres.2018.05.012. Epub 2018 May 25.
PMID: 29804931
citation: Ebisch SJH, Aleman A. The fragmented self: imbalance between intrinsic and extrinsic self-networks in psychotic disorders. Lancet Psychiatry. 2016 Aug;3(8):784-790. doi: 10.1016/S2215-0366(16)00045-6. Epub 2016 Jun 30.
PMID: 27374147
citation: Newen A, Vogeley K. Self-representation: searching for a neural signature of self-consciousness. Conscious Cogn. 2003 Dec;12(4):529-43. doi: 10.1016/s1053-8100(03)00080-1.
PMID: 14656496
citation: Synofzik M, Vosgerau G, Newen A. I move, therefore I am: a new theoretical framework to investigate agency and ownership. Conscious Cogn. 2008 Jun;17(2):411-24. doi: 10.1016/j.concog.2008.03.008. Epub 2008 Apr 14.
PMID: 18411059
citation: Shaqiri A, Roinishvili M, Kaliuzhna M, Favrod O, Chkonia E, Herzog MH, Blanke O, Salomon R. Rethinking Body Ownership in Schizophrenia: Experimental and Meta-analytical Approaches Show no Evidence for Deficits. Schizophr Bull. 2018 Apr 6;44(3):643-652. doi: 10.1093/schbul/sbx098.
PMID: 29036731
citation: Germine L, Benson TL, Cohen F, Hooker CI. Psychosis-proneness and the rubber hand illusion of body ownership. Psychiatry Res. 2013 May 15;207(1-2):45-52. doi: 10.1016/j.psychres.2012.11.022. Epub 2012 Dec 28.
PMID: 23273611
citation: Fusar-Poli P, Cappucciati M, Borgwardt S, Woods SW, Addington J, Nelson B, Nieman DH, Stahl DR, Rutigliano G, Riecher-Rossler A, Simon AE, Mizuno M, Lee TY, Kwon JS, Lam MM, Perez J, Keri S, Amminger P, Metzler S, Kawohl W, Rossler W, Lee J, Labad J, Ziermans T, An SK, Liu CC, Woodberry KA, Braham A, Corcoran C, McGorry P, Yung AR, McGuire PK. Heterogeneity of Psychosis Risk Within Individuals at Clinical High Risk: A Meta-analytical Stratification. JAMA Psychiatry. 2016 Feb;73(2):113-20. doi: 10.1001/jamapsychiatry.2015.2324.
PMID: 26719911
responsible party type: Sponsor
mesh term: Psychotic Disorders
mesh term: Mental Disorders
sharing ipd: Undecided