临床试验/ISRCTN83290762

ISRCTN83290762

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Fluoxetine Or Control Under Supervision (FOCUS): a multicentre randomised trial to establish the effect(s) of routine administration of Fluoxetine in patients with a recent stroke

niversity of Edinburgh and NHS Lothian (UK)0 个研究点目标入组 3,127 人2012年5月23日

概览

阶段: 未知
干预措施: 未指定
疾病 / 适应症: 未指定
发起方: niversity of Edinburgh and NHS Lothian (UK)
入组人数: 3127
状态: 已完成
最后更新: 5年前

概览研究者入排标准结局指标相似试验

概览

简要总结

2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26289352 2017 statistical and health economic analysis plan in https://www.ncbi.nlm.nih.gov/pubmed/29282099 2019 results in http://www.ncbi.nlm.nih.gov/pubmed/30528472 2019 exploratory analyses in https://www.ncbi.nlm.nih.gov/pubmed/31426731 (added 01/04/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32452356/ (added 27/05/2020)

注册库

who.int

开始日期

2012年5月23日

结束日期

2017年10月1日

最后更新

5年前

研究类型

Interventional

性别

All

研究者

发起方

niversity of Edinburgh and NHS Lothian (UK)

入排标准

入选标准

•1\. Age \> 18 years
•2\. Brain imaging is compatible with intracerebral haemorrhage or ischaemic stroke
•3\. Randomisation can be performed between 2 and 15 days after stroke onset
•4\. Persisting focal neurological deficit is present at the time of randomisation severe enough to warrant 6 months trial treatment from the patient's or carer's perspective

排除标准

•1\. Subarachnoid haemorrhage
•2\. Unlikely to be available for follow up at 12 months
•3\. Patient and/or carer unable to understand spoken or written English
•4\. Other life\-threatening illness
•5\. Pregnant or breast\-feeding or of child bearing age not taking contraception
•6\. History of epileptic seizures
•7\. Attempted suicide or self\-harm
•8\. Allergy or contra indication to fluoxetine
•9\. Taken a monoamine oxidase inhibitor in last 5 weeks
•10\. Current or recent depression requiring treatment with selective serotonin reuptake inhibitor

结局指标

主要结局

未指定

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