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

niversity of Edinburgh0 个研究点目标入组 3,127 人开始时间: 2012年1月6日最近更新: 2019年2月28日

试验速览

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•1. New acute stroke 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. Stroke deficits limiting function at the time of randomisation
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 1000
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 2000

•<18 years old • Subarachnoid haemorrhage, although where this is secondary to an intracerebral haemorrhage the patient will be eligible • Unlikely to be available for follow-up e.g. no fixed home address. Unable to speak English unless they have a close friend or relative who can act as a translator/interpretor • Patient has other life threatening illness (e.g. advanced cancer) likely to lead to death within a few months. • Depression requiring pharmacological treatment with a Selective Serotonin Reuptake Inhibitor (SSRI) Drug. (i.e. the same class of drug as Fluoxetine) • Pregnant or breast-feeding woman, women of child bearing age not taking contraception • History of epileptic seizures • Allergy to, or contraindications to fluoxetine including: o Hepatic failure o Renal failure (eGFR < 30ml/min) o Taken a monoamine oxidase inhibitor in last 5 weeks Co- administration of Fluoxetine and a Mono Amine Oxidase Inhibitors (MAOI) may result in life threatening interactions. Therefore, patients on MAOI inhibitors are ineligible for the FOCUS trial. Also, any patient needing treatment with a MAOI must stop their trial treatment for at least 5 weeks before commencing the MAOI). We will allow co-enrollment to another CTIMP, providing we can attribute adverse events to each specific IMP.

发起方

niversity of Edinburgh