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/NCT05986409</url>
    </required_header>
    <id_info>
      <org_study_id>20140101</org_study_id>
      <nct_id>NCT05986409</nct_id>
    </id_info>
    <brief_title>Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia</brief_title>
    <official_title>The Role of Microbiota-gut-brain Axis as a Mediator in the Association Between Indoor Artificial Light at Night and the Relapse Risk of Schizophrenia: a Randomized, Crossover Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Weizhuo Yi</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Anhui Medical University</source>
    <oversight_info>
      <has_dmc>No</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>
        A randomized crossover trial of ALAN intervention was conducted in patients with chronic&#xD;
        schizophrenia in Anhui Mental Health Center from August 15 to September 30, 2022. All&#xD;
        participants met the diagnostic criteria for schizophrenia in the fifth edition of the&#xD;
        Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The enrolled patients were in&#xD;
        the symptom-stable phase and were regularly prescribed antipsychotics (no change in&#xD;
        medication regimen). The diets of all the participants were uniformly supplied during study.&#xD;
        Patients with infectious diseases, eye diseases, or gastrointestinal diseases, or who used&#xD;
        antibiotics at the time of recruitment, were excluded. The wards of the participants were all&#xD;
        located in the same inpatient building. All included wards had the same size, layout,&#xD;
        lighting and orientation of doors and windows. In normal conditions, each ward retains a&#xD;
        small LED lamp (the same layout in all wards) at night as a source of lighting.&#xD;
  &#xD;
        The study was divided into two stages. In the first stage, 10 wards were randomly selected as&#xD;
        the intervention group (opaque black tape covering part of the light source), and another 10&#xD;
        wards were selected as the control group (no intervention). After a two-week washout&#xD;
        interval, the second stage was carried out, with the two groups interchanging interventions.&#xD;
        At the end of each intervention, participants completed a structured questionnaire scale to&#xD;
        assess the relapse risk of schizophrenia, and then their fecal samples were collected.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">August 1, 2022</start_date>
    <completion_date type="Actual">September 30, 2022</completion_date>
    <primary_completion_date type="Actual">September 15, 2022</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>Crossover Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Relapse risk</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>Relapse risk was assessed by Chinese version of the Early Signs Scale (ESS). The ESS scale consists of 34 items (e.g., recently been bothered by 1 or 2 small things in life; To feel down and down; Other people don't understand me; Difficulty concentrating; It feels as if the thoughts are not my own... Etc.). Each entry is rated from 0 points (0 times/week), 1 score (1 time/week), 2 scores (more than 1 time/week) to 3 scores (at least 1 time/day), and all entries total 102 scores. The ESS scale has 4 dimensions, which are: Anxiety/agitation (ESS-A, 7 items); Depression/withdrawal (ESS - N, 10 items); Excitability/disinhibition (ESS-D, 6 items); Incipient psychosis (ESS-IP, 11 items).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Cognitive function</measure>
      <time_frame>up to 24 weeks</time_frame>
      <description>The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening test designed to assess various cognitive functions, including memory, attention, language, and visuospatial abilities. It was created by Dr. Ziad Nasreddine in Montreal, Canada, in 1996, and it has since become a valuable tool for detecting mild cognitive impairment (MCI) and early signs of dementia, especially Alzheimer's disease.&#xD;
  The MoCA consists of a series of tasks and questions that evaluate different cognitive domains. The total score on the MoCA is 30 points, with a higher score indicating better cognitive function. A score of 26 or above is considered normal for most individuals, although the normal range can vary based on factors such as age and education level.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">50</enrollment>
    <condition>Schizophrenia Relapse</condition>
    <condition>Light Pollution</condition>
    <arm_group>
      <arm_group_label>opaque black tape covering part of the light source</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>no intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>another 10 wards were selected as the control group (no intervention)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>light cover</intervention_name>
      <description>10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention).</description>
      <arm_group_label>opaque black tape covering part of the light source</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of schizophrenia&#xD;
  &#xD;
            -  Regularly taking antipsychotics&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infectious diseases&#xD;
  &#xD;
            -  Gastrointestinal diseases&#xD;
  &#xD;
            -  Using antibiotics&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rubing Pan, Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Anhui Medical University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Weizhuo Yi</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230031</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Anhui Medical University</investigator_affiliation>
      <investigator_full_name>Weizhuo Yi</investigator_full_name>
      <investigator_title>Director</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Recurrence</mesh_term>
      <mesh_term>Schizophrenia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05986409
  org study id: 20140101
  nct id: NCT05986409
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A randomized crossover trial of ALAN intervention was conducted in patients with chronic
        schizophrenia in Anhui Mental Health Center from August 15 to September 30, 2022. All
        participants met the diagnostic criteria for schizophrenia in the fifth edition of the
        Diagnostic and Statistical Manual of Mental Disorders (DSM-V). The enrolled patients were in
        the symptom-stable phase and were regularly prescribed antipsychotics (no change in
        medication regimen). The diets of all the participants were uniformly supplied during study.
        Patients with infectious diseases, eye diseases, or gastrointestinal diseases, or who used
        antibiotics at the time of recruitment, were excluded. The wards of the participants were all
        located in the same inpatient building. All included wards had the same size, layout,
        lighting and orientation of doors and windows. In normal conditions, each ward retains a
        small LED lamp (the same layout in all wards) at night as a source of lighting.
  
        The study was divided into two stages. In the first stage, 10 wards were randomly selected as
        the intervention group (opaque black tape covering part of the light source), and another 10
        wards were selected as the control group (no intervention). After a two-week washout
        interval, the second stage was carried out, with the two groups interchanging interventions.
        At the end of each intervention, participants completed a structured questionnaire scale to
        assess the relapse risk of schizophrenia, and then their fecal samples were collected.
  allocation: Randomized
  intervention model: Crossover Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Relapse risk
  time frame: up to 24 weeks
  description: Relapse risk was assessed by Chinese version of the Early Signs Scale (ESS). The ESS scale consists of 34 items (e.g., recently been bothered by 1 or 2 small things in life; To feel down and down; Other people don't understand me; Difficulty concentrating; It feels as if the thoughts are not my own... Etc.). Each entry is rated from 0 points (0 times/week), 1 score (1 time/week), 2 scores (more than 1 time/week) to 3 scores (at least 1 time/day), and all entries total 102 scores. The ESS scale has 4 dimensions, which are: Anxiety/agitation (ESS-A, 7 items); Depression/withdrawal (ESS - N, 10 items); Excitability/disinhibition (ESS-D, 6 items); Incipient psychosis (ESS-IP, 11 items).
  measure: Cognitive function
  time frame: up to 24 weeks
  description: The Montreal Cognitive Assessment (MoCA) is a widely used cognitive screening test designed to assess various cognitive functions, including memory, attention, language, and visuospatial abilities. It was created by Dr. Ziad Nasreddine in Montreal, Canada, in 1996, and it has since become a valuable tool for detecting mild cognitive impairment (MCI) and early signs of dementia, especially Alzheimer's disease.
  The MoCA consists of a series of tasks and questions that evaluate different cognitive domains. The total score on the MoCA is 30 points, with a higher score indicating better cognitive function. A score of 26 or above is considered normal for most individuals, although the normal range can vary based on factors such as age and education level.
  arm group label: opaque black tape covering part of the light source
  arm group type: Experimental
  description: 10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source).
  arm group label: no intervention
  arm group type: No Intervention
  description: another 10 wards were selected as the control group (no intervention)
  intervention type: Other
  intervention name: light cover
  description: 10 wards were randomly selected as the intervention group (opaque black tape covering part of the light source), and another 10 wards were selected as the control group (no intervention).
  arm group label: opaque black tape covering part of the light source
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Rubing Pan, Dr.
  role: Principal Investigator
  affiliation: Anhui Medical University
  facility: 
  country: China
  responsible party type: Sponsor-Investigator
  investigator affiliation: Anhui Medical University
  investigator full name: Weizhuo Yi
  investigator title: Director
  mesh term: Recurrence
  mesh term: Schizophrenia
  sharing ipd: No