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临床试验/NCT01455038
NCT01455038已完成不适用

Heart Rate Variability of Patients With Bipolar Disorder in Subsyndromal Depressive Phase

Asan Medical Center1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
1
主要终点
Heart rate variability (HRV)

研究概览

简要总结

The purposes of this study were: (1) to compare heart rate variability between bipolar patients in subsyndromal depressive phase and healthy controls (2) to evaluate the relation between the severity of subsyndromal depressive symptoms and reduced heart rate variability.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Bipolar group:
  • DSM-IV bipolar disorder
  • Montgomery-Åsberg depression rating scale (MADRS) score for last one month : ≤ 10
  • Clinical Global Impression severity (CGI-S) for last one month : ≤ 3
  • Healthy controls group: Subjects had no history of psychiatric disorder and had no psychiatric symptom when interviewed by a board-certified psychiatrist.

排除标准

  • Psychiatric disorder except bipolar disorder
  • Neurological symptoms or signs
  • History of head trauma
  • History of cardiovascular diseases
  • Any medication except psychiatric medication.

结局指标

主要结局

Heart rate variability (HRV)

时间窗: at baseline

Time domain - NN (normal-to-normal R-R interval), HRV index (total number of all NN/ the height of the histogram of all NN), SDNN (standard deviation of the NN), RMSSD (the root mean square of differences of successive NN), NN50 (Number of pairs of adjacent NN intervals differing by more than 50 ms in the entire recording) and pNN50(NN50/total number of all NN). Frequency domain - TP (The variance of NN intervals over the temporal segment), VLF(Power in very low frequency range; \<0.04 Hz), LF(Power in low frequency range; 0.04\~0.15 Hz), HF(Power in high frequency range; 0.15\~0.4 Hz)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Yeon-Ho Joo

Professor

Asan Medical Center

研究点 (1)

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