Study of Functional Networks in Resting fMRI as Biomarkers of Monopolar or Bipolar Depression
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 37
- 主要终点
- Bold signal and connectivity coefficients within and between neural networks
研究概览
简要总结
The primary purpose is to compare with resting fMRI the functional networks of rest (RTS) in unipolar depression and in bipolar depression.
Hypothesis : the main objective of this work is to compare with the rest fMRI the Rest Functional Networks (RFN) in the unipolar depression and in the bipolar depression in order to identify specific biomarkers for each affection. The general hypothesis of this work is that intra- and inter RFN connectivity is different between bipolar patients and unipolar patients. Specifically the investigators assume that connectivity within the default mode network (including ventral mediofrontal cortex, subgenual cingulate cortex, inferior parietal cortex, posterior cingulate cortex) will be increased in unipolar patients compared to bipolar patients.
详细描述
Study hypothesis:
The investigators assume that connectivity within the DMR will be increased in unipolar patients compared to bipolar patients. Similarly the investigators assume, in agreement with the results of our studies using N-Back (Harvey et al, 2005) and studies in self reference process in the unipolar depression (Grimm et al, 2009; and Lemogne al, 2009) that the DMR and frontoparietal networks connectivity (intraparietal cortex and dorsolateral prefrontal cortex) will be unusually positive in unipolar patients compared to bipolar patients.
Methods:
Transversal, multicenter, comparative study evaluating unipolar and bipolar patients in depressive phase and controls group without psychiatric disorders. The study involves one single assessment with fMRI, which is used to characterize a mono or bipolar major MDE. The question is not to predict subsequent progression towards a unipolar or bipolar disorder.
Primary outcome :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- 是
入选标准
- •Unipolar and bipolar depressed patients including patients with type I and type II bipolar disorders.
- •Patients in an acute depressive state (according to DSM-IV criteria).
- •Men or Women with age between 18 to 65 years.
- •Patients with unipolar depression must fullfill Mitchel's criteria for unipolar depression.
- •MADRS score > 22
- •YMRS score < 12
- •Mean duration of depressive episode < 1 year
- •in-patient or out-patient
- •Healthy volunteers matched for age and socio-educational level, without personal history of unipolar or bipolar depression and without psychiatric disorders
排除标准
- •Patients and controls:
- •Bipolar disorder with rapid cycling
- •Suicidal thoughts with score > 3 at the MADRS item 'suicide'
- •Depression with psychotic features
- •Psychiatric co-morbidity including other AXIS-1 disorders (OCD, schizophrenia, social phobia) and borderline personality disorder
- •Substance and alcohol abuse or dependance
- •Recent treatment with ECT (< 6 months)
- •Previous history of Brain Traumatic Injury; neurological disorders (multiple sclerosis, parkinson's disease, stroke) or disorders associated with abnormal MRI (lupus, Behcet's disease)
- •Contra-indication of MRI: pregnancy; tatoos; claustrophobia
- •Patient hospitalized under legal condition
- •Patient that requires an important sedation due to anxiety
- •Bipolar patients that requires at less 3 mood stabilizers
- •Patient receiving a new antidepressant since more than 10 days
- •Patients without social security insurance
- •Patients with legal protection
研究组 & 干预措施
Bipolar disorder type I or II
a single resting state fMR for patients with bipolar disorder type I or II with acute depressive state
干预措施: Resting state fMRI (Other)
Unipolar disorder
a single resting state fMR for patients with monopolar disorder with acute depressive state
干预措施: Resting state fMRI (Other)
Healthy volunteers
a single resting state fMRI for subjects without psychiatric disorders assessed by the SCID
干预措施: Resting state fMRI (Other)
结局指标
主要结局
Bold signal and connectivity coefficients within and between neural networks
时间窗: one day (within 16 days after inclusion)
Bold connectivity assessed with resting state fMRI within and between networks
次要结局
- Sensibility and specificity of fMRI to predict unipolar and bipolar depressive status(one day (within 16 days after inclusion))
- Correlations between clinical scores (MADRS, YMRS, SCID) and neural network connectivity.(one day (within 16 days after inclusion))