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Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial
Open accessDennis, Martin, Mead, Gillian, Forbes, John, Graham, Catriona, Hackett, Maree, Hankey, Graeme J, House, Allan, Lewis, Stephanie, Lundström, Erik, Sandercock, Peter, Innes, Karen, Williams, Carol, Drever, Jonathan, Mcgrath, Aileen, Deary, Ann, Fraser, Ruth, Anderson, Rosemary, Walker, Pauli, Perry, David, Mcgill, Connor, Buchanan, David, Chun, Yvonne, Dinsmore, Lynn, Maschauer, Emma, Barugh, Amanda, Mikhail, Shadia, Blair, Gordon, Hoeritzauer, Ingrid, Scott, Maggie, Fraser, Greig, Lawrence, Katherine, Shaw, Alison, Williamson, Judith, Burgess, David, Macleod, Malcolm, Morales, Dan, Sullivan, Frank, Brady, Marian, French, Ray, Van Wijck, Frederike, Watkins, Caroline, Proudfoot, Fiona, Skwarski, Joanna, Mcgowan, Diane, Murphy, Rachael, Burgess, Seona, Rutherford, William, Mccormick, Katrina, Buchan, Ruaridh, Macraild, Allan, Paulton, Ruth, Fazal, Adnan, Taylor, Pat, Parakramawansha, Ruwan, Hunter, Neil, Perry, Jack, Bamford, John, Waugh, Dean, Veraque, Emelda, Bedford, 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Charlotte, Oakley, Susan, Blight, Adrian, Peixoto, Cassilda, Jones, Suzanne, Livingstone, Gaybrielle, Butler, Fiona, Bradfield, Sally, Gordon, Laura, Schmit, Jenneke, Wijewardane, Anika, Edmunds, Tineke, Wills, Rebecca, Medcalf, Catherine, Argandona, Lucia, Cuenoud, Larissa, Hassan, Hanna, Erumere, Esther, Ocallaghan, Aidan, Gompertz, Patrick, Redjep, Ozlem, Auld, Grace, Howaniec, Laura, Song, Anna, Tarkas, Tillana, Kabash, Hashim, Hungwe, Rumbi·2019·The Lancet
Abstract
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. METHODS: FOCUS was a pragmatic, multicentre, parallel group, double-blind, randomised, placebo-controlled trial done at 103 hospitals in the UK. Patients were eligible if they were aged 18 years or older, had a clinical stroke diagnosis, were enrolled and randomly assigned between 2 days and 15 days after onset, and had focal neurological deficits. Patients were randomly allocated fluoxetine 20 mg or matching placebo orally once daily for 6 months via a web-based system by use of a minimisation algorithm. The primary outcome was functional status, measured with the modified Rankin Scale (mRS), at 6 months. Patients, carers, health-care staff, and the trial team were masked to treatment allocation. Functional status was assessed at 6 months and 12 months after randomisation. Patients were analysed according to their treatment allocation. This trial is registered with the ISRCTN registry, number ISRCTN83290762. 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. 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. FUNDING: UK Stroke Association and NIHR Health Technology Assessment Programme.
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Metadata
- Authors
- 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., 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, C. K., 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., Kamara, C., Bowler, H., Bell, S., Jackson, T., Harkness, K., Stocks, K., Duty, S., Doyle, C., Dunn, G., Endean, K., Claydon, F., Richards, E., Howe, J., Lindert, R., Majid, A., Dakin, K., Maatouk, A., Barron, L., Meegada, M., Rana, P., Nair, A., Brighouse-Johnson, C., Greig, J., Kyu, M., Prasad, S., Robinson, M., Alam, I., Mclean, B., Greenhalgh, L., Ahmed, Z., Roffe, C., Brammer, S., Beardmore, C., Finney, K., Barry, A., Hollinshead, P., Grocott, J., Maguire, H., Natarajan, I., Chembala, J., Sanyal, R., Lijko, S., Abano, N., Remegoso, A., Ferdinand, P., Stevens, S., Varquez, R., Causley, C., Butler, A., Whitmore, P., Stephen, C., Carpio, R., Hiden, J., Muddegowda, G., Denic, H., Sword, J., Curwen, R., James, M., Mudd, P., Hall, F., Cageao, J., Keenan, S., Roughan, C., Kingwell, H., Hemsley, A., Lohan, C., Davenport, S., Bowring, A., Chapter, T., Hough, M., Strain, D., Gupwell, K., Miller, K., Goff, A., Cusack, E., Todd, S., Partridge, R., Jennings, G., Thorpe, K., Stephenson, J., Littlewood, K., Barber, M., Brodie, F., Marshall, S., Esson, D., Coburn, I., Mcinnes, C., Ross, F., Bowie, E., Barcroft, H., Withers, V., Miller, L., Willcoxson, P., Donninson, M., Evans, R., Daniel, D., Coyle, J., Keeling, M., Wanklyn, P., Elliott, M., Wightman, J., Iveson, E., Dyer, N., Porteous, A.-M., Haritakis, M., Ward, M., Doughty, L., Carr, L., O Neill, M., Anazodo, C., Wood, P., Cottrell, P., Donne, C., Rodriguez, R., Mir, R., Westmoreland, J., Bell, J., Emms, C., Wright, L., Clark Brown, P., Bamford, E., Stanners, A., Carpenter, M., Datta, P., Davey, R., Needle, A., Eastwood, M. 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- Venue
- The Lancet
- Publisher
- Elsevier BV
- Published
- 2019-01
- Volume
- 393
- Issue
- 10168
- Pages
- 265-274
- ISSN
- 0099-5355 (ISSN-L)
- 0140-6736
- OpenAlex
- W2902979281
- Cited by
- 287
- References
- 32
- FWCI
- 29.36
- Type
- journal article
- Language
- en
- Open access
- hybrid
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
How to cite
Cite CoChat for the checks on this page, and the paper for its own findings.
- This page
- CoChat. (2026). Citation check: Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial. https://app.cochat.ai/papers/10.1016/s0140-6736(18)32823-x
- The paper
- 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. https://doi.org/10.1016/s0140-6736(18)32823-x
Data sources
Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.
