AFFINITY
Trial question
What is the role of fluoxetine in patients after acute stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
37.0% female
63.0% male
N = 1280
1280 patients (476 female, 804 male)
Inclusion criteria: adult patients with acute stroke, brain imaging consistent with ischemic or hemorrhagic stroke, and a persisting neurological deficit
Key exclusion criteria: indication or contraindication for fluoxetine; life-threatening disease with < 12-month survival; pregnancy
Interventions
N=642 fluoxetine (an oral dose of 20 mg/day for 6 months)
N=638 placebo (matching placebo daily for 6 months)
Primary outcome
New depression at 6 months
5
7
7.0 %
5.3 %
3.5 %
1.8 %
0.0 %
Fluoxetine
Placebo
No significant difference ↔
No significant difference in new depression at 6 months (5% vs. 7%; ARD -2, 95% CI -4.59 to 0.59)
Secondary outcomes
Borderline significant increase in fatigue at 6 months as measured by the vitality subscale of 36-item short form health survey (70 vs. 70 ; )
No significant difference in health-related QoL as measured by the European QoL 5-dimensional 5-level questionnaire (0.81 vs. 0.78 ; AD 0.03 , 95% CI 0 to 0.06)
Safety outcomes
No significant differences in death, recurrent stroke, thrombotic events, hemorrhagic stroke.
Significant differences in epileptic seizures (2% vs. < 1%), fall with injury (3% vs. 1%), and new bone fracture (3% vs. 1%) at 6 months.
Conclusion
In adult patients with acute stroke, brain imaging consistent with ischemic or hemorrhagic stroke, and a persisting neurological deficit, fluoxetine was not superior to placebo with respect to new depression at 6 months.
Reference
AFFINITY Trial Collaboration. Safety and efficacy of fluoxetine on functional outcome after acute stroke (AFFINITY): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):651-660.
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