Basal Plasma Lithium Levels and Suicidal Events (LIPS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 158
- 试验地点
- 1
- 主要终点
- Patients rate with lithium levels above 0.1 µeq/L
研究概览
简要总结
Suicidal behavior is a major public health issue and there are currently no specific treatments for it.
However, lithium, the reference treatment for bipolar disorder, have been shown to be effective in preventing suicidal risk.
Apart from drug treatments, lithium is present in our environment and its levels varies from one individual to another, depending, especially, on diet.
Knowing that patients with a mood disorder generally have a poor lifestyle and a less rich and varied diet than the general population, variations in basal lithium levels can be expected in these patients.
详细描述
This study aims to assess the rate of depressed patients (unipolar or bipolar) with basal plasma lithium levels above 0.1 µeq/L.
It also aims to :
- compare basal plasma lithium levels according to the occurrence of a suicidal event in the year prior to inclusion ;
- assess the association of lithium levels with the intensity of current suicidal ideation ;
- assess the association of lithium levels with impulsiveness ;
- assess the association of lithium levels with characteristics of bipolar disorder (for patients with bipolar disorder) ;
- assess the association of lithium levels with emotional lability ;
- assess, in the patients with a suicidal event in the year prior to the inclusion, the association of lithium levels with the characteristics of suicide attempts
To do so, 158 patients currently suffering from a major depressive disorder and who have not received any lithium treatment over the last year, will be included and divided in two groups :
- Depressed patients with a history of suicidal event over the last 12 months (suicide attempters/ideations) ;
- Depressed patients with no history of suicidal event over the last 12 months (affective controls).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •18 years old or over
- •Current major depressive episode according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders) criteria
- •No lithium-based treatment over the last 12 months
- •For suicide attempters/ideations only : suicidal event over the last 12 months
- •For affective controls only : no suicidal event over the last 12 months
排除标准
- •Lifetime diagnosis of schizoaffective disorder, schizophrenia or psychosis
- •Pregnancy or breastfeeding
- •Deprivation of freedom (by judicial or administrative decision)
- •Legal protection measure (guardianship or curators)
- •Inability to understand experimental procedures
- •No affiliation to the French National Social Security System
- •No consent to participate in the study
结局指标
主要结局
Patients rate with lithium levels above 0.1 µeq/L
时间窗: Baseline
Rate of patients with basal plasma lithium levels, assessed at baseline, above the threshold of 0.1 µeq/L
次要结局
- Bipolar disorder characteristics(Baseline)
- Current suicidal ideation(Baseline)
- Basal plasma lithium levels(Baseline)
- Impulsiveness level(Baseline)
- Aggression level(Baseline)
- Suicide attempt characteristics(Baseline)
- Emotional lability(Baseline)