AI-based Multi-center Research on Identification/Classification/Aided Diagnosis of Mood Disorder

Sponsor
First Affiliated Hospital of Zhejiang University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05608135
Collaborator
(none)
960
1
49.8
19.3

Study Details

Study Description

Brief Summary

At present, diagnosis and recognition of depression and bipolar disorder are mainly based on subjective evidence such as clinical interview and scale evaluation. The corresponding diagnosis basis has some shortcomings, such as poor diagnostic reliability and failure in early identification of bipolar disorder. Therefore, it is of great significance to explore objective diagnostic indicators to remedy the deficiencies.

Therefore,the investigators collect psychological and physiological information data of patients with bipolar disorder and depression.Then the investigators aim to construct and verify the multidimensional emotion recognition model to analyze the personality characteristics, negative emotions and cognitive reactions of different individuals, and form a systematic accurate recognition and evaluation tool.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    960 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Recognition/Classification/Auxiliary Diagnosis of Affective Disorder Based on AI:A Multi-center Study
    Actual Study Start Date :
    Oct 8, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2025

    Outcome Measures

    Primary Outcome Measures

    1. facial action unit detection [Baseline]

      The research recruits subjects to look at pictures and videos and then use cameras to record facial microexpressions. Finally, the research uses machine learning methods to analyze facial micro-expressions. Facial micro-expressions (MEs) are involuntary movements of the face that occur spontaneously when a person experiences an emotion but attempts to suppress or repress the facial expression, typically found in a high-stakes environment.

    2. event-related potentials [Baseline]

      An electroencephalogram (EEG) is a test that measures electrical activity in the brain using small, metal discs (electrodes) attached to the scalp. Brain cells communicate via electrical impulses and are active all the time, even during asleep. This activity shows up as wavy lines on an EEG recording. The research recruits subjects to look at videos and pictures and use electroencephalography to record event-related potentials. Finally, we use time domain analysis and frequency analysis to get the results

    3. Galvanic skin response [Baseline]

      The skin also has electrical activity, which is in constant, slight variation, and can be measured and charted. The skin's electrical conductivity fluctuates based on certain bodily conditions, and this fluctuation is called the galvanic skin response.We recruited subjects to watch videos and pictures and record galvanic skin response. Finally, we use time domain analysis and frequency analysis to get the results

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Age 15-55, regardless of gender;

    2. The brief International Neuropsychiatric Interview Chinese version (MINI) was used to meet the diagnostic criteria for DSM-IV-TR depressive disorder or bipolar disorder (type I);

    3. Total score of Hamilton Depression Scale (HAMD-17) ≥17, and Young's Manic Scale (YMRS) ≤6;

    4. Junior high school or above.

    Exclusion Criteria:
    1. The patient conforms to DSM-IV schizophrenia and related spectrum disorders.

    2. The patient has a history of severe head trauma (loss of consciousness for more than 5 minutes), current or previous history of epilepsy, intracranial hypertension, or other serious neurological diseases;

    3. Had a history of alcohol or psychoactive substance abuse/dependence in the 6 months prior to the test;

    4. Those considered unsuitable for inclusion by the researcher.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of Zhejiang University Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • First Affiliated Hospital of Zhejiang University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hu ShaoHua, Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University Affiliation: First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Zhejiang University
    ClinicalTrials.gov Identifier:
    NCT05608135
    Other Study ID Numbers:
    • IIT20210021B-R2
    First Posted:
    Nov 8, 2022
    Last Update Posted:
    Nov 9, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hu ShaoHua, Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University Affiliation: First Affiliated Hospital of Zhejiang University, First Affiliated Hospital of Zhejiang University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 9, 2022