Effects of fluoxetine on functional outcomes after acute stroke (FOCUS): a pragmatic, double-blind, randomised, controlled trial
2019
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- Duncan Bailey
- Luciano García Alén
- Latheef Kalathil
- Sarah Tinsley
- Taya Jones
- Kelly Amor
- Andrew Ritchings
- Emma Margerum
- Jane Horton
- Richard A. Miller
- Nireekshana Gautam
- Julie Meir
- Amaryl Jones
- Janet Putteril
- Mirella Lepore
- Rachel Gallifent
- Laura-Louise Arundell
- Catherine Mcredmond
- Alicia Goulding
- Vivek Nadarajan
- Julia Laurence
- Su Fung Lo
- Sabina Melander
- Paul Nicholas
- Elizabeth Woodford
- Gillian McKenzie
- Vietland Le
- Jacolene Crause
- Robert Luder
- Maneesh Bhargava
- Girish Bhome
- Venetia Vettimootal Johnson
- Dara Chesser
- Hayley Bridger
- Elodie Murali
- J. F. Scott
- Susan Morrison
- Amy Burns
- Julie Graham
- Madeline Duffy
- Khalid Ali
- Emma Pitcher
- Jane Gaylard
- Julie Newman
- Sunil Punnoose
- Sarah Besley
- Kirtan Purohit
- Amy Rees
- Mark Davy
- Osman Chohan
- Muhammad Fozan Khan
- Rachel Walker
- Vicky Murray
- Charlotte Bent
- Susan Oakley
- Cassilda Peixoto
- Suzanne Jones
- Gaybrielle Livingstone
- Fiona. Butler
- Sally Bradfield
- Laura Gordon
- Jenneke Schmit
- Anika Wijewardane
- Tineke Edmunds
- Rebecca Wills
- Catherine Medcalf
- Lucía Argandoña
- Larissa Cuenoud
- Hanna Hassan
- Esther Erumere
- Aidan Ocallaghan
- Patrick Gompertz
- Ozlem Redjep
- Grace Auld
- Anna Song
- Tillana Tarkas
- Hashim Kabash
- Rumbi Hungwe
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. 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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