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 人开始时间: 2012年5月23日最近更新: 2020年6月8日

试验速览

•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

•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
•11. Already participating in a Clinical Trial of an Investigational Medical Product

发起方

niversity of Edinburgh and NHS Lothian (UK)