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临床试验/NCT01903655
NCT01903655已完成不适用

Study of the Telomere-telomerase System and the Expression of Candidate Genes in the Leukocytes of Patients With Depressive Disorder: Search for Peripheral Markers of Somatic Stress

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Telomere length

研究概览

简要总结

The mechanisms of oxidative stress and inflammation involved in mood disorders are factors of chronicity and severity. These mechanisms induce a phenomenon of accelerated cellular senescence and are reflected by alterations in systemic gene expression detectable in leukocytes in peripheral blood. The genetic markers of these mechanisms are clinically significant markers. The identification of new genetic markers will make it possible to improve evaluations of the severity and somatic consequences of depressive syndromes.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Persons who have given their written informed consent
  • absence of a diagnosis of major depressive disorder throughout the study and no history of psychiatric disorders
  • diagnosis of a first episode of a major depressive disorder
  • diagnosis of a recurrent major depressive disorder (at least three episodes) with or without resistance to therapy
  • the diagnosis of major depressive disorder with characteristics of melancholy must be clearly mentioned in the case report form but is not a reason for not being included in the study
  • the presence of a recent or older attempted suicide must lead to a careful clinical assessment of the diagnosis of depressive disorder and must be clearly mentioned in the case report form.

排除标准

  • Persons not covered by the national Health Insurance Agency
  • Psychotic or bipolar disorders
  • Severe personality disorders
  • cardiovascular disease, proven inflammatory disease and cancer
  • persons unable to give their consent personally,
  • persons in emergency situations,
  • pregnant women,
  • breast-feeding women

研究组 & 干预措施

patients with recurrent depressive disorder

Other

a group of patients with recurrent depressive disorder according to DSM-IV-TR including depressive episodes with melancholic features (at least three episodes of depression)

干预措施: telomere length (Other)

control group

Other

patient with no depressive disorder during the study period and no psychiatric history

干预措施: telomere length (Other)

patients with a first episode of major depressive disorder

Other

a group of patients with a first episode of major depressive disorder according to DSM-IV-TR including depressive episodes with melancholic features

干预措施: telomere length (Other)

结局指标

主要结局

Telomere length

时间窗: participants will be followed for the duration of hospital stay, an expected average of 6 months

次要结局

  • level of oxidative stress.(participants will be followed for the duration of hospital stay, an expected average of 6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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