Comparative Study of Physiological and Cerebrovascular Reactivity in Depression, at the Three Phases of Emotion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
研究概览
简要总结
The main objective is to compare the physiological reactivity (heart and respiratory rates, galvanic skin response, cerebral perfusion, and startle) in the three phases of emotion between depressive subjects, subjects remitted from depression and control subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Female between 18 and 55
- •Informed consent form signed
- •Affiliated to a medical insurance
- •visual and hearing abilities suitable for exams
- •for the depressive group (group D): major depressive disorder according to the DSM-IV criteria as evaluated by the MINI test and MADRS score ≥22
- •for the depressive patients in remission's group (group R) : matched on age, at least 1 history of major depressive disorder in the last 10 years and solved for more than 6 months, and MADRS score < 9
- •for the control subjects (group T) : matched on age, no psychiatric history, MADRS score < 9
排除标准
- •psychotic disorder, bipolar disorder, addiction, suspected dementia (MMSE<25)
- •current betablockers or neuroleptics treatment
- •any current organic unstable pathology
- •history of serious cardiovascular disease (coronary syndrome, cardiac arrythmia, etc.)
- •smoking > 10 PY
- •history of serious neurologic disease (stroke, cerebral tumour, serious cranial trauma, headache, ...)
- •contra-indication to MRI
- •uncorrected vision or audition troubles
- •patient under juridic protection
- •pregnancy, lactating or female without reliable contraception
研究组 & 干预措施
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
干预措施: psychometric tests (Behavioral)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
干预措施: MRI (Device)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
干预措施: transcranial doppler and TPI (Device)
3 groups of subjects
3 groups: depressive subjects, subjects remitted from depression and control subjects, with the same interventions.
psychometric tests, MRI, transcranial doppler and TPI, explicitative interview
干预措施: explicitative interview (Behavioral)
结局指标
主要结局
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle as measure of physiological reactivity
时间窗: one day
amplitude variations of heart and respiratory rate, cerebral pulsatility, galvanic skin response and startle.
次要结局
- score of psychometric tests as measure of emotional state(one day)
- MRI data as measure of cerebral perfusion, volume of leukoaraiosis and default network (fMRI at rest)(one day)
- ultrasound data of doppler as measure of cerebral pulstility(one day)
- spontaneous verbal production to emotional pictures and explicitative interviews(one day)