NCT05939154

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
21 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 11, 2023

Status Verified

November 1, 2022

Enrollment Period

2.2 years

First QC Date

July 2, 2023

Last Update Submit

July 2, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Building a multi-modal database of major mental disorders

    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.

    at August 2025

Study Arms (2)

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.

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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;
  • Age 15-60;
  • Han nationality;
  • gender is not limited;
  • have enough audition level to complete the necessary inspection of the research;
  • 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.

You may not qualify if:

  • Mental retardation that significantly affects the patient's current mental state;
  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, 200030, China

Location

Related Publications (8)

  • GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6.

    PMID: 27733282BACKGROUND
  • Huang Y, Wang Y, Wang H, Liu Z, Yu X, Yan J, Yu Y, Kou C, Xu X, Lu J, Wang Z, He S, Xu Y, He Y, Li T, Guo W, Tian H, Xu G, Xu X, Ma Y, Wang L, Wang L, Yan Y, Wang B, Xiao S, Zhou L, Li L, Tan L, Zhang T, Ma C, Li Q, Ding H, Geng H, Jia F, Shi J, Wang S, Zhang N, Du X, Du X, Wu Y. Prevalence of mental disorders in China: a cross-sectional epidemiological study. Lancet Psychiatry. 2019 Mar;6(3):211-224. doi: 10.1016/S2215-0366(18)30511-X. Epub 2019 Feb 18.

    PMID: 30792114BACKGROUND
  • Phillips MR, Zhang J, Shi Q, Song Z, Ding Z, Pang S, Li X, Zhang Y, Wang Z. Prevalence, treatment, and associated disability of mental disorders in four provinces in China during 2001-05: an epidemiological survey. Lancet. 2009 Jun 13;373(9680):2041-53. doi: 10.1016/S0140-6736(09)60660-7.

    PMID: 19524780BACKGROUND
  • Kessler RC, Avenevoli S, Costello J, Green JG, Gruber MJ, McLaughlin KA, Petukhova M, Sampson NA, Zaslavsky AM, Merikangas KR. Severity of 12-month DSM-IV disorders in the National Comorbidity Survey Replication Adolescent Supplement. Arch Gen Psychiatry. 2012 Apr;69(4):381-9. doi: 10.1001/archgenpsychiatry.2011.1603.

    PMID: 22474106BACKGROUND
  • Rominger A, Cumming P, Brendel M, Xiong G, Zach C, Karch S, Tatsch K, Bartenstein P, la Fougere C, Koch W, Pogarell O. Altered serotonin and dopamine transporter availabilities in brain of depressed patients upon treatment with escitalopram: A [123 I]beta-CIT SPECT study. Eur Neuropsychopharmacol. 2015 Jun;25(6):873-81. doi: 10.1016/j.euroneuro.2014.12.010. Epub 2015 Jan 5.

    PMID: 25819144BACKGROUND
  • Gunaratne P, Lloyd AR, Vollmer-Conna U. Mood disturbance after infection. Aust N Z J Psychiatry. 2013 Dec;47(12):1152-64. doi: 10.1177/0004867413503718. Epub 2013 Sep 20.

    PMID: 24056922BACKGROUND
  • Merikangas KR, Swendsen J, Hickie IB, Cui L, Shou H, Merikangas AK, Zhang J, Lamers F, Crainiceanu C, Volkow ND, Zipunnikov V. Real-time Mobile Monitoring of the Dynamic Associations Among Motor Activity, Energy, Mood, and Sleep in Adults With Bipolar Disorder. JAMA Psychiatry. 2019 Feb 1;76(2):190-198. doi: 10.1001/jamapsychiatry.2018.3546.

    PMID: 30540352BACKGROUND
  • Haque A, Milstein A, Fei-Fei L. Illuminating the dark spaces of healthcare with ambient intelligence. Nature. 2020 Sep;585(7824):193-202. doi: 10.1038/s41586-020-2669-y. Epub 2020 Sep 9.

    PMID: 32908264BACKGROUND

MeSH Terms

Conditions

Mental Disorders

Study Officials

  • Yiru Fang, Doctorate

    Shanghai Mental Health Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiru Fang, Doctorate

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2023

First Posted

July 11, 2023

Study Start

August 1, 2023

Primary Completion

September 30, 2025

Study Completion

December 31, 2025

Last Updated

July 11, 2023

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

The project team provides a multimodal data acquisition platform, establishes a shared data management committee, formulates data sharing mechanisms, and defines the rights and obligations of data contributors, data beneficiaries, and the multimodal information system.

Locations