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临床试验/NCT02427789
NCT02427789已完成不适用

Therapeutic Effectiveness of Exercise Associated to the Pharmacotherapy in Major Depression

University of Sao Paulo General Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3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
40
试验地点
2
主要终点
Physical exercise evaluation

研究概览

简要总结

Depression is a disorder that causes major harm to physical health and social life. It induces isolation, reduced physical and work capacity and increasing the risk of death. In contrast, exercise helps to maintain quality of life, also inducing improvement of cognitive functions, stimulation of brain plasticity and resilience, in addition to promoting self-esteem and social interaction. The precise mechanisms by which exercise improves symptoms of depression are not fully clear, but it is probably multifactorial. In this project, the investigators aim to investigate variables that provide additional information about biomarkers involved in the pathophysiology of depression and therapeutic response to exercise. The investigators expect to find changes in biomarkers associated with potential mechanisms of neuroprotection (cytokines, markers of oxidative stress, Brain-derived neurotrophic factor (BDNF), cortisol) after exercise program and the role in the therapeutics of depression. To evaluate functional assessment indices will be used ergospirometry, a test that determines the respiratory, cardiovascular and metabolic activity. Overall, this project will help to investigate alternative adjunctive treatments for depression and their associated biomarkers with response.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Major Depression Disorder According Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
  • Score higher or equal 18 in Hamilton Depression Rating Scale
  • Age between 18 and 55 years old

排除标准

  • Unstable Clinical Diseases
  • Patients Unable to make Physical Exercises
  • Present frequencies below 90% attendance in the program aerobic fitness

结局指标

主要结局

Physical exercise evaluation

时间窗: One year

Evaluate the physical exercise influence on the symptoms, according to HAM-D criteria, at the end of training program.

次要结局

  • Biomarkers level comparison(One year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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