Investigation on Risk Factors for Suicide Among Chinese P... | NCT07281729

Studies
Investigation on Risk Factors for Suicide Among Chinese Patients With Mood Disorders

NCT07281729

Sponsor

Shanghai Mental Health Center

Status

Enrolling by invitation

Last Update Posted

Dec 15, 2025Actual

Enrollment

25,000Estimated

Phase

Not provided

Conditions

Bipolar Disorder；Major Depressive Disorder；Mood Disorders

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 1, 2025Actual

Primary Completion Date

Jun 30, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

Dec 2, 2025

First Submission Date that Met QC Criteria

Dec 12, 2025

First Posted Date

Dec 15, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 12, 2025

Last Update Posted Date

Dec 15, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Main research objective: Through questionnaire surveys, obtain the occurrence levels of self-harm/suicide behaviors, the status of acquired suicidal ability, and their correlations with self-harm/suicide behaviors among patients with mood disorders in mental specialty hospitals and general hospitals.

Main research purpose: (1) Conduct a comprehensive assessment and analysis of the occurrence of suicide/self-harm behaviors, the level of acquired suicidal ability, and their distribution among patients with mood disorders in China; (2) Compare the characteristics and acquired suicidal ability status of patients with mood disorders in mental specialty hospitals and general hospitals' psychological outpatient departments regarding suicide/self-harm behaviors; (3) From multiple dimensions, explore the influencing factors of self-harm/suicide behaviors and acquired suicidal ability in patients with mood disorders, form a list of suicide risk factors and clarify the key risk factors, establish a predictive model for acquired suicidal ability; (4) Through follow-up on whether patients have another occurrence of suicide behavior, clarify the impact of key risk factors on the occurrence of suicide behavior, and verify the effectiveness of the predictive model for acquired suicidal ability.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

25,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Suicidal behavior/suicide death questionnaire	The one-year follow-up work for 1000 patients (including the main center and 9 representative sub-centers) was completed. Suicidal behavior/suicide death was used as the primary outcome indicator. The follow-up was conducted once every 3 months (via offline interviews; if the patient was unable to come in person, telephone visits were considered), and the content included whether suicidal/self-harming behavior occurred, the current status, and the baseline part of the questionnaire, etc.	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Aged between 16 and 60 years;Presenting at psychiatric hospital or psychological department of general hospital;Willing to cooperate and participate in this study;Informed consent is signed (with additional informed consent provided by guardian for adolescents);Meeting the diagnostic criteria for Mood Disorders as defined by ICD-11.

Exclusion Criteria:

Inable to comprehend the questionnaire content;Severe organic diseases (e.g., cardiovascular, cerebrovascular, hepatic, or renal impairments) and physically debilitated conditions influencing questionnaire completion;Other situations where participants are unable or unwilling to complete the questionnaire.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

60 Years

Standard Ages

ChildAdult

Study Population

Including people with mood disorders of different ages, genders, occupations, educational levels and cultural backgrounds

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shanghai Mental Health Center		Shanghai	Shanghai Municipality	200030	China
Shanghai Mental Health Center

IPD Sharing Statement Module

Plan to Share IPD

Description

The prescription data will not be shared with the public. However, if the intervention is effective, the educational materials will be released to the public

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided