Characterization of Rhythmic Markers Associated With the Response to Antidepressants
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- significant difference of temperature amplitude between responder and non-responder
研究概览
简要总结
The study aims to characterize the rhythmic parameters of unipolar depressed patients that are associated with the response to antidepressants after 6 weeks of treatment.
详细描述
Patients are included at the time of their hospitalization in the psychiatry unit. They perform rhythmic parameters recording within 48hours after the initiation of the antidepressant treatment. An evaluation of the evaluation of the severity of depression symptoms is performed at 2, 4 and 6 weeks after the initiation of the antidepressant treatment.
A correlation analysis will be performed with rhythmic parameters and the response to the antidepressant treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •current unipolar major depressive disorder according to the Diagnostic ans Statistics Manual (DSM)V
- •MADRS score > 25
排除标准
- •other psychiatric disorder
- •current treatment with thymoregulating agent
- •clozapine treatment
- •heart disease that could alter heart rate characteristics
- •disease associated with fever
- •shift work within 3 months before inclusion
- •transmeridian travel in the preceding month
- •guardianship
研究组 & 干预措施
responder
responder to antidepressant treatment
干预措施: rhythmic parameter recording (Other)
responder
responder to antidepressant treatment
干预措施: psychiatric assessment (Behavioral)
non responder
non responder to antidepressant treatment
干预措施: rhythmic parameter recording (Other)
non responder
non responder to antidepressant treatment
干预措施: psychiatric assessment (Behavioral)
结局指标
主要结局
significant difference of temperature amplitude between responder and non-responder
时间窗: 6 weeks
the response to the antidepressant treatment is determined by the variation of the MADRS score between pretreatment and 6 weeks of treatment. the complete response is obtained when the MADRS score has at least a 50% decrease after 6 weeks.
significant difference of activity duration between responder and non-responder
时间窗: 6 weeks
significant difference of RR interval of the heart rate between responder and non-responder
时间窗: 6 weeks
次要结局
未报告次要终点