Assessment of fluoxetine in stroke recovery trial

Lead PI:  Prof Graeme J Hankey and A/Prof Maree L. Hackett

Status: Closed

No. of Patients Currently Recruited: 1600                             No. of Patients Required:  1600

An Australian-lead investigator initiated, multi-centre, prospective, randomized, parallel group, double blind placebo-controlled trial to establish the effect(s) of routine administration of fluoxetine (20mg once daily) for 6 months in patients with recent stroke on functional outcome at 6 months and one year.

Primary Aim: Does treatment with fluoxetine, 20 mg once daily, started 2-15 days after stroke onset and continued for 180 days, improve functional outcome at 180 days after randomisation?

AFFINITY has two sister trials FOCUS (UK) and EFFECTS (Sweden) 

Trial URL:

ANZCTR No: ACTRN12611000774921  

24 June 2021