Fluoxetine does not reduce symptoms of clinical depression in patients who have had a stroke

In patients recovering from ischemic or hemorrhagic stroke, treatment with fluoxetine did not reduce symptoms of clinically significant depression compared to placebo, according to study results published in JAMA Neurology.

The current study was a secondary analysis of the randomized, double-blind, placebo-controlled, parallel-group study evaluating fluoxetine in stroke recovery (AFFINITY). The study included 1,221 patients enrolled in Australia, New Zealand and Vietnam between 2013 and 2019 who recently had a stroke. Patients were randomized in a 1: 1 ratio to receive either 6 months of oral fluoxetine 20 mg (n = 614) or placebo (n = 607). Symptoms of depression were assessed using the 9-item patient health questionnaire (PHQ-9); clinically significant depression was defined as a PHQ-9 score of 9 or greater.

The patients in the fluoxetine group had a mean age of 64.3 ± 12.2 years; 62.3% were men; 85.1% had a history of ischemic stroke; 3.0% had previously been treated for depression; and 2.6% were currently receiving treatment for depression. The patients in the placebo group had a mean age of 63.4 ± 12.4 years; 64.7% were men; 86.1% had a history of ischemic stroke; 4.9% had previously been treated for depression; and 2.4% were currently receiving treatment for depression.

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In patients in the fluoxetine and placebo groups, clinically significant reductions in symptoms of depression were found in 12.8% and 14.6% after 4 weeks, 10.8% and 9.7% after 12 weeks and 7.0, respectively % and 8.2% reported at 26 weeks, respectively. Of the patients who reported PHQ-9 scores of 9 or greater, 20.2% were in the fluoxetine group and 21.1% were in the placebo group.

Study results showed that the symptoms of depression decreased over time in patients in both groups (odds ratio [OR], 0.96; 95% CI, 0.80-1.27; P <0.001) and that those treated with fluoxetine had no significantly reduced symptoms of depression (OR 1.01; 95% CI 0.80-1.27; P = 0.94). In addition, the researchers did not observe any significant treatment-by-time interaction (OR range 0.83-1.16; all P ³, 34).

Factors that were not found to be significantly associated with depression outcomes included gender (P = .11), study location (P = .77), history of depression (P = .87), and stroke type (P = .94). .

The study was limited by only including patients with stable disease with mild to moderate cognitive deficits after a stroke. This limitation may have led to the relatively reduced prevalence of clinically significant depression reported during the study.

The researchers concluded, “Current approaches to preventing and treating clinically significant symptoms of depression after stroke require systematic assessment and mitigation of modifiable risk factors for depression, standardized diagnostic measures and personalized interventions that are effective and safe, rather than the routine prescription of antidepressants. “For all patients.”

Disclosure: Some study authors stated links with biotech, pharmaceutical, and / or device manufacturers. For a full list of specifications, see the original reference.


Almeida OP, Hankey GJ, Ford A, et al. Depression outcomes in patients treated with fluoxetine for stroke recovery: the AFFINITY randomized clinical trial. JAMA Neurol. Published online August 2, 2021. doi: 10.1001 / jamaneurol.2021.2418

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