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临床试验/NCT07523490
NCT07523490招募中不适用

Investigation on Suicide Risk Factors of Patients With Mood Disorders in China

Tianjin Anding Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2025年12月31日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
300
试验地点
1
主要终点
Columbia Suicide Severity Rating Scale

研究概览

简要总结

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.).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
16 Years 至 60 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

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.

结局指标

主要结局

Columbia Suicide Severity Rating Scale

时间窗: 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.

次要结局

  • Beck Scale for Suicide Ideation(baseline, 3 months)
  • Hamilton Depression Rating Scale(baseline, 3 months)
  • Hamilton Anxiety Rating Scale(baseline, 3 months)
  • Patient Health Questionnare(baseline, 3 months)
  • Generalized Anxiety Disorder(baseline, 3 months)
  • acquired capability for suicide scale(baseline, 3 months)
  • Interpersonal Needs Questionnaire(baseline, 3 months)
  • Beck Hopelessness Scale(baseline, 3 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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