Bipolar Disorder；Major Depressive Disorder；Mood DisordersNCT07281729
Investigation on Risk Factors for Suicide Among Chinese Patients With Mood Disorders
An observational study of Bipolar Disorder；Major Depressive Disorder；Mood Disorders, run by Shanghai Mental Health Center at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Bipolar Disorder；Major Depressive Disorder；Mood Disorders
- How many people
- 25,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Aug 2025to 30 Jun 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Including people with mood disorders of different ages, genders, occupations, educational levels and cultural backgrounds
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
Shanghai Mental Health Center
Shanghai, Shanghai Municipality, 200030
Shanghai Mental Health Center
Shanghai, Xuhui, 200030
About this study
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2025
- Study start1 Aug 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder；Major Depressive Disorder；Mood DisordersStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PENG, Daihui, Shanghai Mental Health Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07281729
- Sponsor's protocol ID
- 2025-IIT06
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2025
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Risk Factors for Suicide Among Chinese Patients With Mood Disorders
- ClinicalTrials.gov ID
- NCT07281729
- Acronym / sponsor ID
- 2025-IIT06
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 15 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Including people with mood disorders of different ages, genders, occupations, educational levels and cultural backgrounds
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Suicidal behavior/suicide death questionnaire
Time frame: 1 year
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bipolar Disorder；Major Depressive Disorder；Mood Disorders, run by Shanghai Mental Health Center at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Suicidal behavior/suicide death questionnaire (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.