- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07281729
Investigation on Risk Factors for Suicide Among Chinese Patients With Mood Disorders
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.
Study Overview
Status
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200030
- Shanghai Mental Health Center
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Xuhui
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Shanghai, Xuhui, China, 200030
- Shanghai Mental Health Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Suicidal behavior/suicide death questionnaire
Time Frame: 1 year
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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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2025-IIT06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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