Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial

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  • Additional Information
    • Subject Terms:
    • Abstract:
      Summary Background Results of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.
    • Abstract:
      Findings Between Sept 10, 2012, and March 31, 2017, 3127 patients were recruited. 1564 patients were allocated fluoxetine and 1563 allocated placebo. mRS data at 6 months were available for 1553 (99·3%) patients in each treatment group. The distribution across mRS categories at 6 months was similar in the fluoxetine and placebo groups (common odds ratio adjusted for minimisation variables 0·951 [95% CI 0·839–1·079]; p=0·439). Patients allocated fluoxetine were less likely than those allocated placebo to develop new depression by 6 months (210 [13·43%] patients vs 269 [17·21%]; difference 3·78% [95% CI 1·26–6·30]; p=0·0033), but they had more bone fractures (45 [2·88%] vs 23 [1·47%]; difference 1·41% [95% CI 0·38–2·43]; p=0·0070). There were no significant differences in any other event at 6 or 12 months.
    • Abstract:
      Interpretation Fluoxetine 20 mg given daily for 6 months after acute stroke does not seem to improve functional outcomes. Although the treatment reduced the occurrence of depression, it increased the frequency of bone fractures. These results do not support the routine use of fluoxetine either for the prevention of post-stroke depression or to promote recovery of function.
    • Abstract:
      Funding UK Stroke Association and NIHR Health Technology Assessment Programme.
    • ISSN:
      0140-6736
    • Accession Number:
      10.1016/S0140-6736(18)32823-X
    • Accession Number:
      S014067361832823X
    • Copyright:
      © 2018 The Author(s). Published by Elsevier Ltd.
  • Citations
    • ABNT:
      DENNIS, M. et al. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. The Lancet, [s. l.], v. 393, n. 10168, p. 265–274, 2019. DOI 10.1016/S0140-6736(18)32823-X. Disponível em: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S014067361832823X. Acesso em: 2 jul. 2020.
    • AMA:
      Dennis M, Mead G, Forbes J, et al. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. The Lancet. 2019;393(10168):265-274. doi:10.1016/S0140-6736(18)32823-X.
    • AMA11:
      Dennis M, Mead G, Forbes J, et al. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. The Lancet. 2019;393(10168):265-274. doi:10.1016/S0140-6736(18)32823-X
    • APA:
      Dennis, M., Mead, G., Forbes, J., Graham, C., Hackett, M., Hankey, G. J., House, A., Lewis, S., Lundström, E., Sandercock, P., Innes, K., Williams, C., Drever, J., Mcgrath, A., Deary, A., Fraser, R., Anderson, R., Walker, P., Perry, D., … Hungwe, R. (2019). Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. The Lancet, 393(10168), 265–274. https://doi.org/10.1016/S0140-6736(18)32823-X
    • Chicago/Turabian: Author-Date:
      Dennis, Martin, Gillian Mead, John Forbes, Catriona Graham, Maree Hackett, Graeme J Hankey, Allan House, et al. 2019. “Effects of Fluoxetine on Functional Outcomes after Acute Stroke (FOCUS): A Pragmatic, Double-Blind, Randomised, Controlled Trial.” The Lancet 393 (10168): 265–74. doi:10.1016/S0140-6736(18)32823-X.
    • Harvard:
      Dennis, M. et al. (2019) ‘Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial’, The Lancet, 393(10168), pp. 265–274. doi: 10.1016/S0140-6736(18)32823-X.
    • Harvard: Australian:
      Dennis, M, Mead, G, Forbes, J, Graham, C, Hackett, M, Hankey, GJ, House, A, Lewis, S, Lundström, E, Sandercock, P, Innes, K, Williams, C, Drever, J, Mcgrath, A, Deary, A, Fraser, R, Anderson, R, Walker, P, Perry, D, Mcgill, C, Buchanan, D, Chun, Y, Dinsmore, L, Maschauer, E, Barugh, A, Mikhail, S, Blair, G, Hoeritzauer, I, Scott, M, Fraser, G, Lawrence, K, Shaw, A, Williamson, J, Burgess, D, Macleod, M, Morales, D, Sullivan, F, Brady, M, French, R, Van Wijck, F, Watkins, C, Proudfoot, F, Skwarski, J, Mcgowan, D, Murphy, R, Burgess, S, Rutherford, W, Mccormick, K, Buchan, R, Macraild, A, Paulton, R, Fazal, A, Taylor, P, Parakramawansha, R, Hunter, N, Perry, J, Bamford, J, Waugh, D, Veraque, E, Bedford, C, Kambafwile, M, Idrovo, L, Makawa, L, Smalley, P, Randall, M, Thirugnana-Chandran, T, Hassan, A, Vowden, R, Jackson, J, Bhalla, A, Rudd, A, Tam, CK, Birns, J, Gibbs, C, Lee Carbon, L, Cattermole, E, Marks, K, Cape, A, Hurley, L, Kullane, S, Smyth, N, Eglinton, C, Wilson, J, Giallombardo, E, Frith, A, Reidy, P, Pitt, M, Sykes, L, Dellafera, D, Croome, V, Kerwood, L, Hancevic, M, Narh, C, Merritt, C, Duffy, J, Cooke, D, Willson, J, Ali, A, Naqvi, A, et al. 2019, ‘Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial’, The Lancet, vol. 393, no. 10168, pp. 265–274, viewed 2 July 2020, .
    • MLA:
      Dennis, Martin, et al. “Effects of Fluoxetine on Functional Outcomes after Acute Stroke (FOCUS): A Pragmatic, Double-Blind, Randomised, Controlled Trial.” The Lancet, vol. 393, no. 10168, Jan. 2019, pp. 265–274. EBSCOhost, doi:10.1016/S0140-6736(18)32823-X.
    • Chicago/Turabian: Humanities:
      Dennis, Martin, Gillian Mead, John Forbes, Catriona Graham, Maree Hackett, Graeme J Hankey, Allan House, et al. “Effects of Fluoxetine on Functional Outcomes after Acute Stroke (FOCUS): A Pragmatic, Double-Blind, Randomised, Controlled Trial.” The Lancet 393, no. 10168 (January 19, 2019): 265–74. doi:10.1016/S0140-6736(18)32823-X.
    • Vancouver/ICMJE:
      Dennis M, Mead G, Forbes J, Graham C, Hackett M, Hankey GJ, et al. Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. The Lancet [Internet]. 2019 Jan 19 [cited 2020 Jul 2];393(10168):265–74. Available from: http://search.ebscohost.com/login.aspx?direct=true&site=eds-live&db=edselp&AN=S014067361832823X