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临床试验/NCT04776226
NCT04776226已完成不适用

Impact of Pots-stroke Depression Treatment on Stroke Recurrence

Ege University1 个研究点 分布在 1 个国家目标入组 1,230 人开始时间: 2017年2月11日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,230
试验地点
1
主要终点
Stroke recurrence

研究概览

简要总结

It is not clear whether depresssion can predispose, or precipitate stroke recurrence in patients with stroke. We sought the relationship of post stroke depression with stroke recurrence.

详细描述

A large body of evidence suggests that depression is associated with a increased risk of many chronic diseases, including hypertension, diabetes, stroke and particularly coronary heart disease. Post stroke depression (PSD) may develop as a result of vascular disease. A previous meta-analysis showed that depression significantly increased the risk of development of stroke, and this increase was probably independent of other risk factors, including hypertension and diabetes.

Clarifying this issue has important implications; if depression increases the risk of development of recurrent stroke, so treating PSD might decrease the occurrence of recurrent stroke. To our knowledge there is no study attempting to clarify the relationship between PSD treatment and stroke recurrence. To fill these gap, we systematically conducted a study to assess whether PSD is associated with recurrent stroke, cardiovascular events or death. Thus, in the current study, three different arms of follow-up of patients with first-ever stroke, were used to predict the outcome over 52 weeks.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

盲法说明

There is no masking

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients who met DSM-IV and V criteria for depression

排除标准

  • Severe or unstable medical disorders (eg, myocardial infarction within past 3 months, end-stage cancer, decompensated cardiac failure)
  • Known primary neurological disorders including dementia, delirium, Parkinson disease, brain tumors, multiple sclerosis, seizure disorder
  • Drugs (eg, systemic steroids)
  • Pancreatic cancer, uncorrected hypothyroidism
  • Current suicidal risk
  • Use of psychotropic prescription or nonprescription drugs, certain hypnotics
  • Mini-Mental State Examination (MMSE) score of 21 or lower

研究组 & 干预措施

Depressive patients with treatment

Experimental

This group included patients wit depression but with treatment during enrollment of the cases.

干预措施: Citalopram (Drug)

结局指标

主要结局

Stroke recurrence

时间窗: 12 months

Standard World Health Organization definitions were used for recurrent stroke

次要结局

  • Cardiovascular Event(12 months)

研究者

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

Prof. Dr. Emre Kumral

Prof. Dr. MD

Ege University

研究点 (1)

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