NCT01213121Unknown4 期
Exploring Alterations of Central Autonomic Modulation in Patients With Bipolar Depression
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart Rate Variability
研究概览
简要总结
- To examine differences in neurophysiologic parameters between unmedicated patients with bipolar depression and healthy controls
- To examine within-subject changes in neurophysiologic parameters in patients with bipolar depression treated with quetiapine
详细描述
- Alterations of neurophysiologic regulation has been suggested in patients with major depressive disorder or bipolar disorders
- Depressive phase of bipolar disorder shows multi-faceted characteristics different from unipolar depression
- Quetiapine is an atypical antipsychotic licensed for treatment of bipolar depression
- The aim of this study is to investigate the pattern of neurophysiologic dysregulation in bipolar depression and its changes induced by quetiapine treatment
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Factorial
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •DSM-IV bipolar disorder I or II
- •Depressive phase
- •Drug-naive or drug-free
排除标准
- •Serious medical or neurological conditions
- •DSM-IV substance-related disorders (within 12 months prior to participation)
- •Mentally retarded
研究组 & 干预措施
bipolar depression
Experimental
unmedicated patients with bipolar depression receiving quetiapine treatment
干预措施: Quetiapine (Drug)
结局指标
主要结局
Heart Rate Variability
时间窗: Six weeks
heart rate variability parameters of time/frequency/complexity domains
次要结局
- Cardio-Respiratory Coupling(Six weeks)
- Electroencephalographic Changes(Six weeks)
- Severity of Mood Symptoms(Six weeks)
- Severity of Extrapyramidal Symptom Scale(Six weeks)
研究者
Jae Seung Chang
Clinical Assistant Professor
Seoul National University Bundang Hospital
研究点 (1)
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