AFFINITY trial A ssessment o F F luoxet IN e I n s T roke recover Y. Co- principal investigators: Hackett M, Hankey GJ. Steering committee: Almeida O, Anderson CS, Beer C, Billot L, Dennis MS, Flicker L, Ford A, Jan S, Mead G. The burden of disability due to stroke.
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Co- principal investigators: Hackett M, Hankey GJ.
Steering committee: Almeida O, Anderson CS, Beer C, Billot L, Dennis MS, Flicker L, Ford A, Jan S, Mead G
Animal studies suggest fluoxetine is effective
?directly improves motor function
? indirectly improves motivation and attention
FLAME trial (Lancet Neurology, 2011;10:123-130)
Adjusted mean Fugl-Meyer motor scale (FMMS) total scores at days 0, 30, and 90
Error bars represent 95% CI
FLAME results promising, however:
We need to know:
Assessment oFFluoxetine IN sTroke recoverY
1 ◦ To determine if taking fluoxetine, 20 mg, once daily, for 6 months, started 2-15 days post acute stroke improves participants’ neurological outcome (functional ability).
2◦ To determine if fluoxetine…
Approached by member of clinical team
Receive patient information leaflet and verbal explanation
They have time to consider whether they wish to take part
They, or their next of kin give consent if wish to join the trial
They provide information which is entered into the trial database
Web-based, central randomisation service
Rx allocation ratio 1:1
Presence of a motor deficit
Presence of aphasia
(i.e. allocates each patients to the Rx that leads to the least difference between the two groups with respect to these features)
Change time of dosing and treatment
Sugarless gum or saliva substitutes
Change time of dosing (earlier or later may help), improve sleep hygiene,
try a different antidepressant, or short course of benzodiazepine, zopiclone, or low dose trazadone
No evidence that asking about suicide increases likelihood of self- harm. Prescribe small amounts of medication.
Consider changing to mirtazapine if it becomes problematic
Autonomic instability,and Hydration, Rx of hyperthermia, and benzodiazepines
Neuromuscular hyperactivity Consider cyproheptadine or chlorpromazine in severe cases
Informed consent and trial specific screen and baseline assessment
Central randomisation 2 to 15 days post-stroke
Intervention group (n=790)
Control group (n=790)
1 month on-intervention assessment
3 month on-intervention assessment and dispensing
End of 6-month intervention assessment
6-month off-intervention (12 month) assessment
FOCUS aims to recruit 3000
If we complete both FOCUS and AFFINITY and enrol 4500 patients we could reliably detect a 4.4% absolute increase in mRS 0-2.
Give fluoxetine 20mg od (but potentially ‘dilute’ treatment effect)
Mirtazipine: favoured by Allan House, literature suggests interactions are uncommon and not serious