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临床试验/NCT02866812
NCT02866812已完成不适用

Prevalence and Factors Associated With the Occurrence of Depression Six Months After an Endovascular Treatment of Intracranial Aneurysm

CHU de Reims2 个研究点 分布在 1 个国家目标入组 133 人开始时间: 2016年3月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
CHU de Reims
入组人数
133
试验地点
2
主要终点
depression

研究概览

简要总结

During the last decade, the embolization has become the treatment of choice for ruptured intracranial aneurysms, to improve the neurological outcome of patients. At the same time, for his safety, she also became the technique allowing prophylactic treatment of unruptured intracranial aneurysms discovered incidentally during imaging exams.

Regarding patients with ruptured intracranial aneurysms, patients who survive often have a reduced quality of life while one in two has a good neurological outcome after embolization. Depression, anxiety and fatigue, whose the psycho-social impact is important, are often cited. This description has often been done without considering the realized type of treatment (surgery or embolization) and mostly of neurological and functional status of the patient remotely (disability or not in daily activities).

Regarding patients with unruptured intracranial aneurysms, they are mostly asymptomatic and embolization is programmed. They would present an cognitive impairment in one case in five at 1 month of treatment.

If depression, fatigue and difficult return to working life are logically found in patients with severe sequelae (disability in daily activities) of their ruptured intracranial aneurysms, the question arises for patients with a ruptured intracranial aneurysms with a favorable evolution and for asymptomatic patients with unruptured intracranial aneurysms.

A precise status of these populations is necessary, especially as the discovery and treatment of their intracranial aneurysms is often early (between 40 and 60 years) and that their good neurological status should allow "a priori" to return easily at the active life.

详细描述

Describe the prevalence of depression among patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mRS inferior or egal to 1).

Study factors associated with the presence of depression in patients treated for intracranial aneurysms, especially in patients with a favorable neurological outcome at 6 months (mRS inferior or egal to 1)

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • patient with endovascular treatment for intracranial aneurysm (ruptured or unruptured)
  • patient older than 18 years
  • patient consenting to participate to the study
  • patient enrolled in the national healthcare insurance program

排除标准

  • patient with anterior treatment for intracranial aneurysm
  • bipolar disorder, schizophrenia or schizoaffective disorder diagnostic

结局指标

主要结局

depression

时间窗: 6 months

Depression evaluated using the Hamilton scale

次要结局

  • tired(6 months)
  • anxiety(6 months)

研究者

发起方
CHU de Reims
申办方类型
Other
责任方
Sponsor

研究点 (2)

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