Wishing to die or self-harm after stroke: A planned secondary analysis of the AFFINITY Randomised Controlled Trial


      • Stroke is associated with increased risk of depression and of suicidal ideation and acts.
      • It is unclear if the routine use of antidepressants after a stroke decreases the cumulative prevalence of suicidal ideation.
      • This randomised controlled trial showed that the cumulative prevalence of recurrent wish to die or self-harm affected 2.5 % and 3.7 % of participants treated with placebo and fluoxetine, respectively, after 52 weeks of follow-up.
      • Routine daily treatment with fluoxetine for 26 weeks neither increases nor decreases the cumulative prevalence of suicidal/death ideation after 26 and 52 weeks.


      We investigated the cumulative prevalence of self-harm ideation among stroke survivors of the AFFINITY trial. We assessed these thoughts with the last item of the PHQ-9, and functional impairment with the modified Rankin Scale (mRS). Of 1221 participants (age 63.9 ± 12.3 years, 775 men), 11 reported wishing to die or self-harm at baseline. By week 52, 36 of 1159 surviving participants had reported wishing to die or self-harm. Treatment with fluoxetine for 26 weeks did not change the prevalence of these thoughts compared with placebo. Clinically significant symptoms of depression were present in 95 % of participants with recurrent self-harm thoughts.
      The study was registered with the Australian and New Zealand Clinical Trials Registry, ACTRN12611000774921.


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