Early Identification of Mental Disorders: Application of a Multi-modal & Domains System

Sponsor
Shanghai Mental Health Center (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05939154
Collaborator
(none)
400
1
29
13.8

Study Details

Study Description

Brief Summary

This study aims to build a multi-modal collection template and establish a multi-modal database of seven mental disorders including depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders by collecting voice information, facial micro-expression, eye tracking, EEG physiology data respectively. This study will contribute to the multi-modal diagnosis of major mental disorders such as depression in the future and realize clinical application.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    400 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
    Anticipated Study Start Date :
    Aug 1, 2023
    Anticipated Primary Completion Date :
    Sep 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    mental disorders

    Patients in Shanghai Mental Health Center; meet ICD-11 or DSM-5 diagnosis of depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders (do not limit subtypes and current disease state); age ≥15 years and < 60 years.

    healthy controls

    Age ≥15 years and < 60 years; gender match with patient group; understand the research content and sign the informed consent; no family history of mental disorders.

    Outcome Measures

    Primary Outcome Measures

    1. Building a multi-modal database of major mental disorders [at August 2025]

      Establish a prediction model by using machine learning methods and build a multi-modal database of major mental disorders to realize the multi-modal diagnosis and curative effect prediction markers for guiding accurate treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Meet the diagnostic criteria of ICD-11 or DSM-5 for depressive disorders, bipolar disorders, schizophrenia, obsessive-compulsive disorder, anxiety disorders, addictive disorders and sleep-wake disorders, and do not limit subtypes and current disease state;

    2. Age 15-60;

    3. Han nationality;

    4. gender is not limited;

    5. have enough audition level to complete the necessary inspection of the research;

    6. Understand the research content and sign the informed consent form. If the patient is unable to sign the informed consent form in person due to low education level or other reasons, he or she can be entrusted to sign it by his relatives or his guardian.

    Exclusion Criteria:
    1. Mental retardation that significantly affects the patient's current mental state;

    2. Patients who have serious physical diseases, and it is difficult to complete the necessary examination, including the history of brain trauma or cerebrovascular disease, severe liver cirrhosis, acute and chronic real failure, severe diabetes, aplastic anemia, moderate and severe malnutrition, other serious physical diseases such as nervous system, heart, liver, kidney, endocrine system and blood system, or diseases that may interfere with the test evaluation (abnormal indexes are more than 2 times higher than normal).

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Mental Health Center Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • Shanghai Mental Health Center

    Investigators

    • Principal Investigator: Yiru Fang, Doctorate, Shanghai Mental Health Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Shanghai Mental Health Center
    ClinicalTrials.gov Identifier:
    NCT05939154
    Other Study ID Numbers:
    • CRC2021DX01
    First Posted:
    Jul 11, 2023
    Last Update Posted:
    Jul 11, 2023
    Last Verified:
    Nov 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 11, 2023