Title: Inflammatory Biomarkers and Brain Metabolites, a Study Based on Magnetic Resonance Spectroscopy.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Glutamine (Glu) and Glutamate (Glx) levels
研究概览
简要总结
Suicidal behaviors (SB) are a major health problem in France : 10 000 suicides and 220 000 suicide attempts every year. SB management is therefore a major public health issue.
Evidence associated dysregulation of the serotonergic system and the hypothalamic-pituitary-adrenal axis to vulnerability to SB. Recent data point to linke these abnormalities with neuroinflammatory clues, glutamatergic function and neuronal plasticity. There is a need to better understand the physiopathology and develop diagnostic and therapeutic tools in SB.
The investigators hypothesize that increased peripheral biomarkers of inflammation would correlate to a disturbance of the cerebral metabolites, such as glutamate and NAA, especially in suicidal patients.
Our aim is to compare rates of cerebral metabolites, in particular the complex glutamine/glutamate, in cerebral areas involved in suicidal vulnerability (the anterior cingulate cortex and the orbito-frontal cortex) between person with unipolar disorder with and without suicidal attempt.
详细描述
69 patients : 23 with suicidal thoughts and attempt, 23 with suicidal thoughts without attempt and 23 healthy volunteers.
2 visits :
- Inclusion visit (V0) : (Day 1)
o Clinical interview : self and hetero assessment questionnaire
-
Visit V1 (as soon as possible, day 1 if available) :
-
MRI (spectroscopy)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Non-specific inclusion criteria:
- •Having signed informed consent
- •Able to understand nature, aims and methodology of the study
- •Specific inclusion criteria :
- •Suicidal patient with suicide attempt :
- •Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
- •Hamilton Depression Scale > 7
- •Suicide attempt < 1 week
- •Suicidal patient without suicide attempt :
- •Persistent depressive disorder according to the Diagnostic and Statistical Manual of Mental Disorders - V (DSM-V) criteria, and evaluated by the Mini International Neuropsychiatric Interview (MINI)
- •Hamilton Depression Scale > 7
- •No history of suicide attempt
- •Healthy volunteers :
- •No psychiatric history
- •No history of suicide attempt
排除标准
- •Actual somatic, neurological or inflammatory pathology (C-Reactive Protein > 10mg/L)
- •Traumatic brain injury with loss of consciousness
- •Antibiotic treatment or anti-inflammatory treatment
- •Actual toxic abuse according to DSM-V (except tobacco and alcohol)
- •Actual or passed history of psychotic disorder
- •Patient on protective measures (guardianship or trusteeship)
- •Deprived of liberty subject (judicial or administrative decision)
- •Pregnant women or breastfeeding
- •Contraindications to MRI scan
研究组 & 干预措施
Participants
All the participants of the 3 groups (depressed patients with suicide attempt, depressed patients without suicide attempt, healthy volunteers) will have to realize a MRI and biological samples.
干预措施: Magnetic Resonance Imaging (MRI) and biological samples (Other)
结局指标
主要结局
Glutamine (Glu) and Glutamate (Glx) levels
时间窗: At V1 (the day of the MRI)
Levels of Glu/Glx in the anterior cingulate cortex and the orbitofrontal cortex between the depressed patients with and without suicide attempt
次要结局
- Link between rate of Interleukin 1, 2, 4, 5, 6, 7, 9, 10, 13 and suicide attempt(At V1 (the day of the MRI))
- Level of N-Acetyl-Aspartate (NAA)(At V1 (the day of the MRI))
- Level of Choline (Cho)(At V1 (the day of the MRI))
- Level of Myo-inositol (Myo)(At V1 (the day of the MRI))
- Level of Creatinine (Cr)(At V1 (the day of the MRI))
- Link between level of depression self assessed with the Beck Scale and metabolites levels(At V1 (the day of the MRI))
- Link between level of suicidal intentionality assessed by the Columbia Suicide Severity Rating Scale (CSS-RS) and metabolites levels(At V1 (the day of the MRI))
- Link between level of depression assessed by the clinician with the Hamilton Rating Scale (HAMD) and metabolite levels(At V1 (the day of the MRI))
- Link between rate of Tumor necrosis factor alpha (TNF α) and suicide attempt(At V1 (the day of the MRI))
- Link between rate of Tumor necrosis factor beta (TNFβ) and suicide attempt(At V1 (the day of the MRI))
- Link between rate of Interferon gamma (IFNγ) and suicide attempt(At V1 (the day of the MRI))
- Link between rate of C-Reactive Protein (CRP) and suicide attempt(At V1 (the day of the MRI))
- Link between rate of Interferon Gamma Inducing Factors (IGIF)and suicide attempt(At V1 (the day of the MRI))