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 sites3,127 target enrollmentJanuary 6, 2012

Overview

No summary available.

Registry

who.int

Start Date

January 6, 2012

End Date

May 16, 2018

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

niversity of Edinburgh

•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.