Plasma Beta-endorphin Levels and Suicidal Behavior
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt.
研究概览
简要总结
It is an interventional research, monocentric, which involves only minimal risks and constraints.
Psychological pain is closely associated with suicidal ideation (SI) and suicidal behavior, regardless of the severity of the depression. The psychological pain being regulated by the opioidergic system, it seems that a dysfunction of this system exists in suicidal attempters. The aim of this study is to explore the association between levels of β-endorphin and suicidal behavior.
The research team will measure plasma levels of β-endorphin in patients hospitalized for suicide attempt (SA) within 72 hours and compare them to those of patients hospitalized for current major depressive episode (EDC) without any lifetime history of SA. In order to follow the kinetics of β endorphin levels, The research team will carry out two measurements: at inclusion and on day 7 (+/- 2 days) of inclusion.
The main objective is to compare plasma β-endorphin levels in patients hospitalized following a recent SA (≤72 hours) and in patients hospitalized for an EDC without lifetime history of SA.
详细描述
104 participants will be enrolled, divided into 2 groups:
group 1: 52 Suicide attempters, currently hospitalized patients for a suicide attempt within the 72 last hours group 2: 50 Affective controls, currently hospitalized patients for current major depressive episode according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria and without any lifetime history of suicide attempt;
The protocol includes two visits.The first visit is the inclusion visit carried out at the beginning of patient hospitalization, within 72 hours following suicide attempt (SA) for group 1 (suicide attempters) and within 72 hours following the admission to hospital for group 2 (affective controls).
The second visit takes place at the end of hospitalisation, on Day 7 +/- 2 days, after SA for group 1 and after admission to hospital for group 2 .
At each visit, a clinical assessment will be performed to characterise psychopathology and suicidal characteristics. Blood samples will be obtained in order to measure beta-β-endorphin levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Common inclusion criteria:
- •Aged between 18 and 65 years old,
- •Subject with a psychiatric diagnosis of current major depressive episode according to DSM-5 criteria
- •Able to understand the nature, purpose and methodology of the study
- •Specific inclusion criteria
- •Suicide attempters: Subject hospitalized for of proven suicide attempt (<72h)
- •Affective controls: Subject hospitalized for a current major depressive episode according to DSM-5 criteria and without any lifetime history of suicidal behavior (proven, interrupted or aborted)
- •Non inclusion criteria
- •Diagnosis of bipolar disorder
- •Lifetime diagnosis of schizoaffective disorder, schizophrenia or unspecified psychosis
- •Current diagnostic of illicit substance / alcohol use disorder within the last 6 months
- •Diabetes or obesity (BMI > 29)
- •Inflammatory disease (e.g. Lupus, Rheumatoid Arthritis)
- •Receiving opiate treatment or opiate substitution treatment
- •Law protected ( guardianship or curatorship)
- •Deprived of liberty (by judicial or administrative decision or forced hospitalization)
- •Pregnant and breastfeeding women
- •Inability to understand, speak and write French
- •Refusal to participate in the study.
- •Not be affiliated to a French National Social Security System
排除标准
- 未提供
研究组 & 干预措施
Suicide attempters
patients hospitalized for suicide attempt within the last 72 hours
干预措施: Blood samples (Biological)
Affective controls
patients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt
干预措施: Blood samples (Biological)
Suicide attempters
patients hospitalized for suicide attempt within the last 72 hours
干预措施: questionnaires (Other)
Affective controls
patients hospitalized for current major depressive episode according to DSM-5 criteria and without any lifetime history of suicide attempt
干预措施: questionnaires (Other)
结局指标
主要结局
Comparison of plasma β-endorphin levels between patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any lifetime history of suicide attempt.
时间窗: Baseline and day 7± 2 days
blood sample between 8:30 a.m. and 9:30 a.m for β-endorphin dosage (pg/mL)
次要结局
- To assess the association between β-endorphin levels and and Suicidal ideation and history of suicidal behavior in the last week before inclusion,(Baseline and day 7± 2 days)
- The level of depression in the last week before inclusion assessed by a self-administered questionnaire (MADRS)(Baseline and day 7± 2 days)
- To assess the association between β-endorphin levels and Anhedonia(Baseline and day 7± 2 days)
- - The kinetics of β-endorphin levels between two measurement points (inclusion and D7+/-2 days) in patients with recent suicide attempt (≤ 72 hours) vs. patients with current major depressive episode without any history of suicide attempt.(Baseline and day 7± 2 days)
- The level of depression in the last week before inclusion assessed by a self-administered questionnaire (QIDS-16)(Baseline and day 7± 2 days)
- To assess the association between β-endorphin levels and Anxiety,(Baseline and day 7± 2 days)
- To assess the association between β-endorphin levels and Current psychological and physical pain as well as usual and maximum over the 15 days before inclusion(Baseline and day 7± 2 days)