<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/NCT04504058</url>
  </required_header>
  <id_info>
    <org_study_id>2020080501</org_study_id>
    <nct_id>NCT04504058</nct_id>
  </id_info>
  <brief_title>Construction of Nutritional Path for Mental Diseases</brief_title>
  <official_title>Construction of Nutritional Optimization Path for Prevention and Treatment of Common Mental Diseases Based on Skin Response Quantification Instrument</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The project will focus on the major technical difficulty of &quot;lack of effective nutritional&#xD;
      intervention measures for early risk of common mental diseases in China&quot;, and rely on the&#xD;
      platform of psychiatric risk identification and treatment specialty of Shanghai Mental Health&#xD;
      Center, an authoritative institution in the field of mental health, and focus on the&#xD;
      effective application of the domestic independent research and development of the artificial&#xD;
      intelligence nicotinic acid skin flushing reaction quantification instrument.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on the biological data of one of the world's largest cohort of psychiatric patients&#xD;
      with early phase and risk, nicotinic acid reaction pictures were introduced as biological&#xD;
      information for the first time in nutritional intervention of psychiatric risk prevention and&#xD;
      control.&#xD;
&#xD;
      Exploration of machine learning and big data analysis methods, based on the objective&#xD;
      quantitative evaluation tool, combined with fingertip blood fat spectrum detection, to&#xD;
      construct the optimization scheme and targeted non drug intervention measures of nutritional&#xD;
      supplement for common mental diseases.&#xD;
&#xD;
      From the perspective of antioxidant stress and nutritional supplement, a new clinical pathway&#xD;
      for the prevention and treatment of mental diseases with artificial intelligence products as&#xD;
      screening, early warning and guidance prevention will be established.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">October 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Conversion to psychosis</measure>
    <time_frame>4 weeks</time_frame>
    <description>It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating &quot;6&quot; refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Poor function</measure>
    <time_frame>4 weeks</time_frame>
    <description>It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Clinical High-risk</condition>
  <arm_group>
    <arm_group_label>UFACH</arm_group_label>
    <description>Unsaturated Fatty Acid in Clinical High-risk</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>routine clinical treatment</intervention_name>
    <description>Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.</description>
    <arm_group_label>UFACH</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      fingertip blood fat spectrum detection&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Help-seeking first-visit participants will be consecutively recruited from the Shanghai&#xD;
        Psychotherapy and Psychological Counselling Centre at the Shanghai Mental Health Centre.&#xD;
        They will be screened for eligibility by their clinicians.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  be aged 14 to 45-year-old；&#xD;
&#xD;
          -  have had at least 6-years of primary education；&#xD;
&#xD;
          -  be drug-naïve；&#xD;
&#xD;
          -  be understanding the survey, be willing to enrol in the study and sign the informed&#xD;
             consent；&#xD;
&#xD;
          -  Through the Structured Interview for Prodromal Syndromes/Scale of Prodromal Symptoms&#xD;
             (SIPS/SOPS), the participants should meet the Criteria of Prodromal Syndrome.&#xD;
             Participants should fulfil at least one of the prodromal syndrome criteria: (1) brief&#xD;
             intermittent psychotic syndrome, (2) attenuated positive symptom syndrome, or (3)&#xD;
             genetic risk and deterioration syndrome.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Through the Mini-International Neuropsychiatric Interview (MINI), Axis I mental&#xD;
             disorders such as schizophrenia, affective disorders, and anxiety spectrum disorders&#xD;
             will be excluded;&#xD;
&#xD;
          -  Acute or chronic renal failure; liver cirrhosis or active liver diseases;&#xD;
&#xD;
          -  Abnormal laboratory tests results judged by the researchers to be clinically&#xD;
             significant and considered to affect the efficacy of the test drugs or the safety of&#xD;
             the subjects;&#xD;
&#xD;
          -  Severe or unstable physical diseases, including: neurological disorders (delirium,&#xD;
             dementia, stroke, epilepsy, migraine, etc.), congestive heart failure, angina&#xD;
             pectoris, myocardial infarction, arrhythmia, hypertension (including untreated or&#xD;
             uncontrolled hypertension), malignant tumours, immune compromise, and blood glucose&#xD;
             above 12 mmol/L;&#xD;
&#xD;
          -  Alcohol abuse within 30 days, or alcohol or drug dependence within 6 months before the&#xD;
             trial;&#xD;
&#xD;
          -  Pregnant or lactating women, or women in childbearing age who are positive in urine&#xD;
             human chorionic gonadotropin test, or men and women who do not take effective&#xD;
             contraceptive measures or plan for pregnancy within 3 months after the initiation of&#xD;
             the trial;&#xD;
&#xD;
          -  Stroke within the last month;&#xD;
&#xD;
          -  Participating in any clinical trial within 30 days before the baseline;&#xD;
&#xD;
          -  Other situations judged by the investigators not to be suitable for the clinical&#xD;
             trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>14 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>TianHong Zhang, Doctor</last_name>
    <phone>13127577024</phone>
    <email>zhang_tianhong@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>TianHong Zhang, Doctor</last_name>
      <phone>13127577024</phone>
      <email>zhang_tianhong@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>March 22, 2021</last_update_submitted>
  <last_update_submitted_qc>March 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shanghai Mental Health Center</investigator_affiliation>
    <investigator_full_name>Tianhong ZHANG</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>nicotinic acid; skin flush reaction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
  </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/NCT04504058
org study id: 2020080501
nct id: NCT04504058
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The project will focus on the major technical difficulty of "lack of effective nutritional
      intervention measures for early risk of common mental diseases in China", and rely on the
      platform of psychiatric risk identification and treatment specialty of Shanghai Mental Health
      Center, an authoritative institution in the field of mental health, and focus on the
      effective application of the domestic independent research and development of the artificial
      intelligence nicotinic acid skin flushing reaction quantification instrument.
Based on the biological data of one of the world's largest cohort of psychiatric patients
      with early phase and risk, nicotinic acid reaction pictures were introduced as biological
      information for the first time in nutritional intervention of psychiatric risk prevention and
      control.

      Exploration of machine learning and big data analysis methods, based on the objective
      quantitative evaluation tool, combined with fingertip blood fat spectrum detection, to
      construct the optimization scheme and targeted non drug intervention measures of nutritional
      supplement for common mental diseases.

      From the perspective of antioxidant stress and nutritional supplement, a new clinical pathway
      for the prevention and treatment of mental diseases with artificial intelligence products as
      screening, early warning and guidance prevention will be established.
observational model: Cohort
time perspective: Prospective
measure: Conversion to psychosis
time frame: 4 weeks
description: It will be determined using the criteria for the Presence of Psychotic Symptoms from SIPS. Specifically, the conversion will be defined by the presence of level 6 positive symptoms (the rating "6" refers to severe and psychotic symptoms) identified as either dangerous, disorganised, or occurring at least one hour a day on average, over four days a week for at least 16 hours.
measure: Poor function
time frame: 4 weeks
description: It will be determined by GAF score. Specifically, poor function outcome is defined as the GAF score of less than 60 at the follow-up point.
arm group label: UFACH
description: Unsaturated Fatty Acid in Clinical High-risk
intervention type: Other
intervention name: routine clinical treatment
description: Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.
arm group label: UFACH
fingertip blood fat spectrum detection
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 14 Years
maximum age: 45 Years
healthy volunteers: No
last name: TianHong Zhang, Doctor
phone: 13127577024
email: zhang_tianhong@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Shanghai Mental Health Center
investigator full name: Tianhong ZHANG
investigator title: Associate Professor
mesh term: Mental Disorders
sharing ipd: Yes
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code