NCT06424613招募中不适用
Investigating the Effects of Lithium Carbonate on Suicide and Self-harm in Adolescents and Young Adults With Bipolar Disorder in China
Peking University1 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年4月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Suicidal ideation
研究概览
简要总结
This study aims to use a retrospective cohort approach to explore the impact of lithium carbonate on suicide and self-harm related events among adolescents and young adults with bipolar disorder in China.The primary objective of this study is to investigate the effects of lithium carbonate on suicidal ideation in adolescents and young adults with bipolar disorder in China. Secondary objectives include exploring its effects on preventing suicide attempts, non-suicidal self-injury, and aggressive behaviors in this population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 12 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 For Lithium group
- •Aged 12-45 years (adolescents 12-17, young adults 18-45).
- •Diagnosed with bipolar disorder using the the Mini-International Neuropsychiatric Interview (M.I.N.I.) (M.I.N.I.; version 5.0) based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria.
- •Adolescents diagnosed using the M.I.N.I. Kid version.
- •Lithium medication adherence of at least 80% in the first six months over the past year.
- •Not in an acute phase of illness.
- •Patient or guardian able to participate in assessment interviews.
- •Informed consent signed by participants and guardians (for adolescents).
- •2 for Non-lithium group
- •Aged 12-45 years (adolescents 12-17, young adults 18-45).
- •Diagnosed with bipolar disorder using the Mini-International Neuropsychiatric Interview (M.I.N.I.; version 5.0) based on DSM-IV criteria.
- •Adolescents diagnosed using the M.I.N.I. Kid version.
- •No lithium use over the past year.
- •Not in an acute phase of illness.
- •Patient or guardian able to participate in assessment interviews.
- •Informed consent signed by participants and guardians (for adolescents).
排除标准
- •Severe physical illness or active substance abuse.
- •Severe cognitive impairments, including developmental delays or dementia.
研究组 & 干预措施
Lithium Group
干预措施: Lithium Carbonate (Drug)
Non-lithium Group
干预措施: Non-lithium medication (Drug)
结局指标
主要结局
Suicidal ideation
时间窗: over the past year
Measured using the Columbia Suicide Severity Rating Scale (C-SSRS)
次要结局
- Non-suicidal self-injury(over the past year)
- Violent and aggressive behaviors(over the past year)
- Suicidal attempt(over the past year)
研究者
研究点 (1)
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