Fluoxetine Or Control Under Supervision (FOCUS)
The FOCUS trial is a randomised controlled trial which aims to find out whether fluoxetine given to people for six months after a stroke improves long-term recovery, even if they do not have depression.
Chief Investigator: Professor Martin Dennis
Number and location of participating sites (by region/ country): UK 91 Active sites
EudraCT number: 2011-0056616-29
ISRCTN number: 83290762
Funder: The Stroke Association
Start and End date of grant award: April 2012 - July 2018
Status: awaiting publication
FOCUS trial website: http://www.focustrial.org.uk/
EFFECT trial website (Sweden): http://www.effects.se/english
Further information: : https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0864-1
Mead G, Hackett ML, Lundstrom E, Murray V, Hankey GJ, Dennis M. The FOCUS, AFFINITY and EFFECTS trials studying the effect(s) of fluoxetine in patients with a recent stroke: a study protocol for three multicentre randomised controlled trials. Trials. 2015 Aug 20;16. 369.
Trial Unblinding Information: Available through system. In circumstances where unblinding is necessary please refer to the protocol and follow instructions provided. Contact details are provided below.
Sponsor: University of Edinburgh and NHS Lothian ACCORD
CI: Professor Martin Dennis; Trial Manager: Karen Innes, Room FU303E, Centre for Clinical Brain Sciences (CCBS), Chancellors Building, 49 Little France Crescent, Edinburgh. EH16 4SB firstname.lastname@example.org
ECTU involvement: Database and randomisation service provision