Investigation on Suicide Risk Factors of Patients With Mood Disorders

April 18, 2026 updated by: Tianjin Anding Hospital

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.).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300000
        • Recruiting
        • Tianjin Anding Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  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.

Exclusion Criteria:

  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Scale for Suicide Ideation
Time Frame: baseline, 3 months
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.
baseline, 3 months
Hamilton Depression Rating Scale
Time Frame: baseline, 3 months
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.
baseline, 3 months
Hamilton Anxiety Rating Scale
Time Frame: baseline, 3 months
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.
baseline, 3 months
Patient Health Questionnare
Time Frame: baseline, 3 months
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.
baseline, 3 months
Generalized Anxiety Disorder
Time Frame: baseline, 3 months
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.
baseline, 3 months
acquired capability for suicide scale
Time Frame: baseline, 3 months
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.
baseline, 3 months
Interpersonal Needs Questionnaire
Time Frame: baseline, 3 months
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.
baseline, 3 months
Beck Hopelessness Scale
Time Frame: baseline, 3 months
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.
baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tianjin Anding Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 31, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MD-SU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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