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临床试验/NCT01272518
NCT01272518Unknown不适用

Assessment of Cardiac Autonomic Behavior in Patients With Mood Disorders With a Focus on the Chaos Theory

Sao Jose do Rio Preto Medical School1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2011年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
20
试验地点
1
主要终点
Hamilton Rating Scale for Depression(HAM-D-17)-17 ; Montgomery & Asberg Rating Scale for Depression(MADRS); Escala de Avaliação de Mania de Bech-Rafaelsen (EAM-BR); Mini International Neuropsychiatric Interview (MINI.

研究概览

简要总结

The purpose of this study is to characterize the behavior of cardiac patients with Mood Disorders and its clinical course, interpreting the results from a theoretical framework of Chaos Theory and Complexity Theory and Systems as well.

详细描述

Mood disorders are strongly associated with changes in cardiovascular function and alterations in Hear Rate Variability (HRV). Fluctuation in heart rate occurs over a wide frequency and demonstrates a broad, irregular variability that suggests that the mechanisms involved in cardiovascular regulation interact in a nonlinear manner. Over the past decade, there has been an increasing emphasis on applying nonlinear methods of analysis to characterize cardiac function, but the studies on the pathophysiology of mood disorders in general still remain under a linear and reductionist perspective. The scarcity of both Brazilian and international studies on the autonomic behavior in mood disorders in general and not only in Major Depressive Disorder, as well as the use of a non-linear reading of the results of this study makes an additional tool of analysis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

入选标准

  • Clinical diagnosis of Bipolar Disorder (BD) or Major Depressive Disorder(MDD)

排除标准

  • Another with criteria for Axis I or II disorders aside from the primary diagnosis of BD or MDD.
  • Past history of stroke, heart attack, or cardiac disease.
  • Drug abuse or dependence in the past six months.
  • Diabetes.
  • In use of Tricyclic Antidepressants

结局指标

主要结局

Hamilton Rating Scale for Depression(HAM-D-17)-17 ; Montgomery & Asberg Rating Scale for Depression(MADRS); Escala de Avaliação de Mania de Bech-Rafaelsen (EAM-BR); Mini International Neuropsychiatric Interview (MINI.

时间窗: 3 months (period between the first and the second assessments)

Both scales for depression and mania will be compared with the linear and nonlinear results from the heart rate variability in the period of 3 months.

次要结局

  • Polar RS800CX hear-rate monitor; Kubios HRV version 2.0 software; Visual Recurrence Analysis software.(3 months (period between the first and the second assessments))

研究者

发起方
Sao Jose do Rio Preto Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Luiz

Guilherme Luiz Lopes Wazen

Sao Jose do Rio Preto Medical School

研究点 (1)

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