Clinical trial NCT05939154: Early Identification of Mental Disorders: Application of a Multi-modal & Domains System
Official title: Shanghai Mental Health Center, Shanghai Jiao Tong University School of Medicine
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Mental Disorder
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2023-07-11
Enrollment: 400
Sex: ALL
Minimum age (years): 15
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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; gender is not limited.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Building a multi-modal database of major mental disorders
timeFrame: at August 2025
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center
name: Yiru Fang, Doctorate
role: PRINCIPAL_INVESTIGATOR
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