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
http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-015-0864-1
http://trialsjournal.biomedcentral.com/articles/10.1186/s13063-017-2385-6