Mood DisordersNCT07523490
Investigation on Suicide Risk Factors of Patients With Mood Disorders
An observational study of Mood Disorders and Suicide, run by Tianjin Anding Hospital at 1 site in China.
Trial summary
This study investigates the level and distribution of suicide risk and learned suicide ability of patients with mood disorders, investigates the related risk factors of suicide and suicide ability formation of patients with mood disorders from multiple dimensions (biological, psychological, social and clinical… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Mood Disorders, Suicide
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 31 Dec 2025to 30 Sep 2027
- How long will I take part?
- 3 Months
- 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: This study will recruit 300 patients meeting the diagnostic criteria of ICD-11 mood disorder.The 300 subjects, aged16 to 60 years old, come from Tianjin Anding Hospital's inpatient/outpatient services and must consent to participate. Exclusion Criteria are as follows:(1) unable to understand the contents of the questionnaire;(2) Serious organic diseases such as cardiovascular disease, brain disease, liver disease and kidney disease, and weak body, which affect the respondents of the questionnaire;(3) Other circumstances that make it impossible or unwilling to cooperate with the completion of the questionnaire.
Who may be able to join
- Age: 16 to 60 years old;
- seeing a doctor in a psychiatric clinic or a general hospital;
- Willing to cooperate in this research project;
- Sign the informed consent form (minors also need to obtain the informed consent signature of the guardian);
- Meet the diagnostic criteria of ICD-11 mood disorder.
Who cannot join
- unable to understand the contents of the questionnaire;
- Serious organic diseases such as cardiovascular disease, brain disease, liver disease and kidney disease, and weak body, which affect the respondents of the questionnaire;
- Other circumstances that make it impossible or unwilling to cooperate with the completion of the questionnaire.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tianjin Anding Hospital
Tianjin, Tianjin Municipality, 300000
Jie Li, jieli@tjmhc.com
About this study
Official title: Investigation on Suicide Risk Factors of Patients With Mood Disorders in China
This study investigates the level and distribution of suicide risk and learned suicide ability of patients with mood disorders, investigates the related risk factors of suicide and suicide ability formation of patients with mood disorders from multiple dimensions (biological, psychological, social and clinical perspectives) and clarifies their importance, forms a list of suicide risk factors, and establishes a prediction model of learned suicide ability formation. Upon enrollment, participants will undergo comprehensive assessments including blood and urine sample collection and scale evaluation. The collection of scientific blood and urine is mainly used for the exploration of molecular mechanism of disease occurrence and development, the discovery and verification of biomarkers. Scale evaluation includes: Beck Scale for Suicide Ideation , Columbia Suicide Severity Rating Scale,, Hamilton Depression Rating Scale , Hamilton Anxiety Rating Scale, PHQ-9, GAD-7, Personal and Social Function Scale , Schihan Disability Scale , Emotional Adjustment Difficulty Scale , Acquired Capability for Suicide Scale, Interpersonal Needs Questionnaire , Ottawa Self-Injury Scale, Chinese version of Stress Perception Scale and Beck Hopelessness Scale . Follow-up was carried out for 3 months, including whether suicide/self-injury occurred, current status, and some baseline questionnaires (such as BSI-CV, GAD-7, PHQ-9, HAMD-17,HAMA, etc.).
- Conditions
- Mood Disorders, Suicide
- Keywords
- Mood Disorders, suicide, Biological Mechanism, prediction model
- Medical subject headings
- Mood Disorders, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with mood disorders | 1. Age: 16 to 60 years old; 2. seeing a doctor in a psychiatric clinic or a general hospital; 3. Willing to cooperate in this research project; 4. Sign the informed consent form (minors also need to obtain the informed consent signature of the guardian); 5. Meet the diagnostic criteria of ICD-11 mood disorder. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Columbia Suicide Severity Rating Scale
Columbia Suicide Severity Rating Scale (C-SSRS) is a tool for evaluating the risk of individual suicide. It includes a series of questions to evaluate the frequency, intensity, persistence and concreteness of individual suicide behavior in the past period of time. The purpose of C-SSRS scale is to distinguish between suicidal ideation and suicidal attempt and higher scores mean a worse outcome. Developed by researchers from Columbia University, the scale is widely used in clinical and research fields to help identify and manage suicide risks.
Measured: baseline, 3 months
Secondary outcomes (8)
Beck Scale for Suicide Ideation
Beck Scale for Suicide Ideation (BSI-CV) assesses the individual's thoughts about life and death and the severity of suicidal thoughts through series of questions. There are 19 items in the scale, which are divided into two dimensions: suicidal ideation and suicidal tendency. Each question is asked for two time periods, that is, the last week and the most depressed, melancholy or suicidal time in the past (that is, the most serious time). The scale adopts a three-level scoring system, that is, 0~2 points, and the total score is between 0~38 points. The higher the score, the stronger the suicidal ideation and the higher the risk of suicide.
Measured: baseline, 3 months
Hamilton Depression Rating Scale
Hamilton Depression Rating Scale (HAMD-17), also known as Hamilton Depression Rating Scale, is a clinical tool for evaluating the severity of depressive symptoms, mainly evaluating patients' depressive symptoms in the past week, including mood, sleep, cognitive function, behavior and physical symptoms. According to the specific performance of patients, doctors or clinical evaluators will give corresponding scores. The total score ranges from 0 to 52 points. The higher the total score, the more serious the depressive symptoms are.
Measured: baseline, 3 months
Hamilton Anxiety Rating Scale
Hamilton Anxiety Rating Scale (HAMA) is a clinical tool for evaluating the severity of anxiety symptoms. The scale was compiled by psychologist Hamilton in 1959, and it is widely used in clinical diagnosis, treatment effect evaluation and research work in psychiatry. HAMA contains 14 items, covering psychological anxiety and physical anxiety. Each item is scored according to the severity of symptoms, and the higher the total score, the more serious the anxiety symptoms are. The total score ranges from 0 to 56 points. Scoring standards are usually divided into four grades: mild, moderate, severe and extremely severe.
Measured: baseline, 3 months
Patient Health Questionnare
Patient Health Question Nare (PHQ-9): It contains 9 questions, mainly focusing on depressed mood, lack of pleasure, sleep disorder, decreased energy, change of appetite, difficulty in concentration, reduced sense of self-worth, negative ideas or suicidal thoughts. Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Measured: baseline, 3 months
Generalized Anxiety Disorder
Generalized Anxiety Disorder-7 (GAD-7): Self-rating anxiety scale, a total of 7 items, respectively: 1 nervous anxiety, 2 uncontrollable worries, 3 excessive worries, 4 inability to relax, 5 akathisia, 6 irritability, 7 sense of foreboding. Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Measured: baseline, 3 months
acquired capability for suicide scale
acquired capability for suicide scale (ACSS): The scale includes two sub-scales: reduced fear of death and improved physical pain tolerance, with a total of 20 topics. Each topic is scored on a 5-point Lickert scale of 1 (completely inconsistent) to 5 (completely consistent), of which 7 topics are reverse scoring. The higher the score, the lower the individual's fear of death and the higher the physical pain tolerance.
Measured: baseline, 3 months
Interpersonal Needs Questionnaire
The Interpersonal Needs Questionnaire (INQ) consists of two subscales: thwarted belongingness (9 items) and perceived burdensomeness (6 items). Each item is scored on a 7-point Likert scale ranging from 1 (not at all true for me) to 7 (very true for me), with 6 items reverse-scored. Scores range from 9 to 63 for thwarted belongingness and from 6 to 42 for perceived burdensomeness. Higher scores indicate greater levels of thwarted belongingness and perceived burdensomeness, reflecting more severe interpersonal distress and unmet interpersonal needs.
Measured: baseline, 3 months
Beck Hopelessness Scale
Beck Hopelessness Scale (BHS): Used to measure the degree of hopelessness that individuals feel. Hopelessness refers to the psychological state in which individuals are pessimistic about the future and believe that their efforts will not bring positive results. This feeling may be associated with depression, anxiety, and other mental health problems. The scale consists of 20 items, with scores ranging from 0 to 20, where higher scores indicate greater levels of hopelessness.
Measured: baseline, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start31 Dec 2025
- Primary completion30 Sep 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- 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
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Tianjin Anding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523490
- Sponsor's protocol ID
- MD-SU
- Status last verified
- Apr 2026
- First submitted
- 5 Apr 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on Suicide Risk Factors of Patients With Mood Disorders in China
- ClinicalTrials.gov ID
- NCT07523490
- Acronym / sponsor ID
- MD-SU
- Conditions
- Mood Disorders, Suicide
- Keywords
- Mood Disorders, suicide, Biological Mechanism, prediction model
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tianjin Anding HospitalUniversity, hospital or other
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 30 Sep 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 13 Apr 2026 (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.
This study investigates the level and distribution of suicide risk and learned suicide ability of patients with mood disorders, investigates the related risk factors of suicide and suicide ability formation of patients with mood disorders from multiple dimensions (biological, psychological, social and clinical perspectives) and clarifies their importance, forms a list of suicide risk factors, and establishes a prediction model of learned suicide ability formation. Upon enrollment, participants will undergo comprehensive assessments including blood and urine sample collection and scale evaluation. The collection of scientific blood and urine is mainly used for the exploration of molecular mechanism of disease occurrence and development, the discovery and verification of biomarkers. Scale evaluation includes: Beck Scale for Suicide Ideation , Columbia Suicide Severity Rating Scale,, Hamilton Depression Rating Scale , Hamilton Anxiety Rating Scale, PHQ-9, GAD-7, Personal and Social Function Scale , Schihan Disability Scale , Emotional Adjustment Difficulty Scale , Acquired Capability for Suicide Scale, Interpersonal Needs Questionnaire , Ottawa Self-Injury Scale, Chinese version of Stress Perception Scale and Beck Hopelessness Scale . Follow-up was carried out for 3 months, including whether suicide/self-injury occurred, current status, and some baseline questionnaires (such as BSI-CV, GAD-7, PHQ-9, HAMD-17,HAMA, etc.).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with mood disorders | – | –1. Age: 16 to 60 years old; 2. seeing a doctor in a psychiatric clinic or a general hospital; 3. Willing to cooperate in this research project; 4. Sign the informed consent form (minors also need to obtain the informed consent signature of the guardian); 5. Meet the diagnostic criteria of ICD-11 mood disorder. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- This study will recruit 300 patients meeting the diagnostic criteria of ICD-11 mood disorder.The 300 subjects, aged16 to 60 years old, come from Tianjin Anding Hospital's inpatient/outpatient services and must consent to participate. Exclusion Criteria are as follows:(1) unable to understand the contents of the questionnaire;(2) Serious organic diseases such as cardiovascular disease, brain disease, liver disease and kidney disease, and weak body, which affect the respondents of the questionnaire;(3) Other circumstances that make it impossible or unwilling to cooperate with the completion of the questionnaire.
Key inclusion criteria (5 listed)
- Age: 16 to 60 years old;
- seeing a doctor in a psychiatric clinic or a general hospital;
- Willing to cooperate in this research project;
- Sign the informed consent form (minors also need to obtain the informed consent signature of the guardian);
- Meet the diagnostic criteria of ICD-11 mood disorder.
Key exclusion criteria (3 listed)
- unable to understand the contents of the questionnaire;
- Serious organic diseases such as cardiovascular disease, brain disease, liver disease and kidney disease, and weak body, which affect the respondents of the questionnaire;
- Other circumstances that make it impossible or unwilling to cooperate with the completion of 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
Columbia Suicide Severity Rating Scale
Time frame: baseline, 3 months
Columbia Suicide Severity Rating Scale (C-SSRS) is a tool for evaluating the risk of individual suicide. It includes a series of questions to evaluate the frequency, intensity, persistence and concreteness of individual suicide behavior in the past period of time. The purpose of C-SSRS scale is to distinguish between suicidal ideation and suicidal attempt and higher scores mean a worse outcome. Developed by researchers from Columbia University, the scale is widely used in clinical and research fields to help identify and manage suicide risks.
8 secondary outcomes
Beck Scale for Suicide Ideation
Time frame: baseline, 3 months
Hamilton Depression Rating Scale
Time frame: baseline, 3 months
Hamilton Anxiety Rating Scale
Time frame: baseline, 3 months
Patient Health Questionnare
Time frame: baseline, 3 months
Generalized Anxiety Disorder
Time frame: baseline, 3 months
acquired capability for suicide scale
Time frame: baseline, 3 months
Interpersonal Needs Questionnaire
Time frame: baseline, 3 months
Beck Hopelessness Scale
Time frame: baseline, 3 months
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 22 Apr 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mood Disorders and Suicide, run by Tianjin Anding Hospital at 1 site 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 5 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Xue Tian (+86-13602182093, 576491743@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Columbia Suicide Severity Rating Scale (time frame: baseline, 3 months). 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 22 Apr 2026.