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. 2019 Nov 26;2019(11):CD009286. doi: 10.1002/14651858.CD009286.pub3

Hankey 2011.

Trial name or title Assessment oF FluoxetINe In sTroke recoverY (AFFINITY) trial
Methods Multicentre
Study type: interventional (clinical trial)
Estimated enrolment: 1600 participants
Allocation: randomised
Intervention model: parallel assignment
Masking: quadruple (participant, care provider, investigator, outcomes assessor)
Primary purpose: treatment
Participants Country: Australia
Setting: inpatient
Inclusion criteria

  • Age > 18 years

  • Clinical diagnosis of stroke 2 to 15 days previously

  • Brain imaging consistent with ischaemic or haemorrhagic stroke (including normal CT brain scan)

  • Persisting measurable focal neurological deficits causing a functional deficit at the time of randomisation


Exclusion criteria:

  • History of epileptic seizures

  • History of bipolar disorder

  • History of drug overdose or attempted suicide

  • Ongoing treatment with any selective serotonin reuptake inhibitor

  • Allergy or contra‐indication to fluoxetine

  • Use of medications that may interact seriously with fluoxetine

  • Not available for follow‐up over the next 365 days e.g. no fixed home address

  • Life‐threatening illness (e.g. advanced cancer) that is likely to reduce 365‐day survival

  • Pregnant, breast‐feeding or of child‐bearing potential and not using contraception

  • Enrolled in another interventional clinical research trial involving an investigational product (medicine) or device


Aiming to recruit 1600 participants
Interventions Fluoxetine 20 mg once daily or matching placebo capsules for 6 months
Outcomes Primary outcome

  • Functional outcome as measured by the mRS at 180 days after randomisation


Secondary outcomes at 180 and 365 days after randomisation

  • Survival

  • Mood (PHQ‐9)

  • Cognitive function (TICSm)

  • Communication (SIS)

  • Motor function (SIS)

  • Overall health status (SIS)

  • Health‐Related Quality of Life (HRQoL) (EuroQol)

  • Functional recovery (smRSq) at the 365‐day assessments

  • New diagnosis of depression requiring treatment with antidepressants

  • Fatigue (vitality domain of the SF‐36)

  • Serious adverse events at any time during follow‐up including new stroke, acute coronary syndrome, epileptic seizures, fall, new fractures or death
Starting date July 2012
Contact information graeme.hankey@health.wa.gov.au
Notes ACTRN12611000774921