ClinicalTrials.gg
RecruitingNCT07523490Updated Apr 22, 2026

Investigation on Suicide Risk Factors of Patients With Mood Disorders

An observational study in Mood Disorders and Suicide, sponsored by Tianjin Anding Hospital. Recruiting at 1 site in China. Open to participants aged 16 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by Tianjin Anding Hospital · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
16 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 17 studies in Mood Disorders with a site in China — 8 open to participants now, 10 under way, 2 of them phase 3. Mood Disorders · China.

Started
2025
with 1 other
Observational
7 of 17
4 open now
Registered
15th of 17
by date

Among the 17 studies in Mood Disorders with a site in China, this one is one of 2 that started in 2025, is one of 7 observational ones, and was the 15th registered.

By phase

17 studies; the count open now beside each. This study's row is marked.

No phase8 · 2 open
Observationalthis study7 · 4 open
Phase 32 · 2 open

By the year they started

First in 2016; this study’s year is marked. 2 started in 2025.

Size and results

Median enrollment 220 across the 10 interventional studies, 400 across the 7 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.

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02

Study 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 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.).

03

Conditions studied

  • Mood Disorders
  • Suicide

Keywords

  • Mood Disorders
  • suicide
  • Biological Mechanism
  • prediction model
04

Who can participate

Ages eligible
16 Years to 60 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Months
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: baseline, 3 months

Secondary outcomes

  1. 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.

    Time frame: baseline, 3 months

  2. 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.

    Time frame: baseline, 3 months

  3. 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.

    Time frame: baseline, 3 months

  4. 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.

    Time frame: baseline, 3 months

  5. 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.

    Time frame: baseline, 3 months

  6. 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.

    Time frame: baseline, 3 months

  7. 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.

    Time frame: baseline, 3 months

  8. 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.

    Time frame: baseline, 3 months

07

Study locations

1 of 1 sites recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Sep 2027, 20 months after the start.

Of 55 non-industry observational studies under Mood Disorders, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 203. This study's planned 20 months is below that.

Counting every sponsor, half of 57 studies reached it within 54 months; a quarter within 27 and three quarters within 203.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 5, 2026
First posted
Apr 13, 2026
StartActual
Dec 31, 2025
Primary completionEst.
Sep 30, 2027
CompletionEst.
Sep 30, 2027
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07523490
Lead sponsor
Tianjin Anding Hospital
Responsible party
Sponsor
First posted
Apr 13, 2026
Start date
Dec 31, 2025
Primary completion
Sep 30, 2027 (estimated)
Completion
Sep 30, 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Xue Tian
Contact
576491743@qq.com
+86-13602182093

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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