EFFECTS
Trial question
What is the role of fluoxetine in patients with acute stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
38.0% female
62.0% male
N = 1500
1500 patients (575 female, 925 male).
Inclusion criteria: adult patients with a clinical diagnosis of ischemic or intracerebral hemorrhage in the previous 2-15 days.
Key exclusion criteria: primary subarachnoid hemorrhage; epileptic seizures; unavailable for follow-up for next 12 months; previous drug overdose or attempted suicide; ongoing depression.
Interventions
N=750 fluoxetine (an oral dose of 20 mg/day for 6 months).
N=750 placebo (matching placebo for 6 months).
Primary outcome
Physical function as measured by stroke impact scale score
76.7 points
77.4 points
77.4 points
58.1 points
38.7 points
19.4 points
0.0 points
Fluoxetine
Placebo
No significant
difference ↔
No significant difference in physical function as measured by the stroke impact scale score (76.7 points vs. 77.4 points; AD -0.7 points, 95% CI -6.06 to 4.66).
Secondary outcomes
Significant decrease in memory as measured by the stroke impact scale score (89.3 points vs. 92.9 points; AD -3.6 points, 95% CI -6.19 to -1.01).
Borderline significant increase in NIHSS (1 point vs. 1 point).
Safety outcomes
No significant differences in death, new stroke, thrombotic events, bleeding events.
Significant differences in new depression (7% vs. 11%), bone fractures (4% vs. 2%), hyponatremia (1% vs. < 1%) at 6 months.
Conclusion
In adult patients with a clinical diagnosis of ischemic or intracerebral hemorrhage in the previous 2-15 days, fluoxetine was not superior to placebo with respect to physical function as measured by the stroke impact scale score.
Reference
EFFECTS Trial Collaboration. Safety and efficacy of fluoxetine on functional recovery after acute stroke (EFFECTS): a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2020 Aug;19(8):661-669.
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