Suicide Prevention by Lithium - the Lithium Intervention Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 167
- 试验地点
- 5
- 主要终点
- occurrence of attempted and completed suicides
研究概览
简要总结
The purpose of this study is to examine the proposed suicide preventive effects of lithium in a randomized controlled trial within a group of individuals with depressive disorders. The hypothesis being tested is that lithium treatment will significantly reduce the risk for another suicide attempt.
详细描述
Several studies have shown that there is a significantly increased risk of suicide related mortality in patients with a positive history of suicide attempts. This study is the first prospective, randomized, double-blind, placebo controlled multi-center trial focussing on the proposed suicide preventive effects of lithium in patients with suicidal behavior but not suffering from bipolar disorder or recurrent major depressive disorder. Patients with a recent history of a suicide attempt are treated with lithium or placebo during a 12 month-period. The hypothesis is that lithium treatment will lead to a 50 % reduction of suicidal behavior.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •suicide attempt within 3 months prior to the first drug administration
- •occurrence of suicide attempt within the context of an affective spectrum disorder
- •minimum age of 18 years
- •ability to complete screening and baseline assessment
- •ability to understand and provide informed consent
排除标准
- •diagnosis of schizophrenia, borderline personality disorder, substance related disorders
- •indication for long-term lithium treatment
- •thyroid disease
- •pregnancy and lactation
研究组 & 干预措施
1
Lithium treatment
干预措施: lithium (Drug)
2
Placebo treatment
干预措施: placebo (Drug)
结局指标
主要结局
occurrence of attempted and completed suicides
时间窗: follow-up period of 1 year
次要结局
- Specific aspects of the suicide attempt/completed suicide(follow-up period of 1 year)