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

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

Footballers and Conductors : Between Reclusiveness and Conviviality

Conviviality has lately become a catchword not only in academia but also among political activists. This open access book discusses conviviality in relation to the adjoining concepts cosmopolitanism and creolisation. The urgency of today’s global predicament is not only an argument for the revival of all three concepts, but also a reason to bring them into dialogue. Ivan Illich envisioned a post-industrial convivial society of ‘autonomous individuals and primary groups’ (Illich 1973), which resembles present-day manifestations of ‘convivialism’. Paul Gilroy refashioned conviviality as a substitute for cosmopolitanism, denoting an ability to be ‘at ease’ in contexts of diversity (Gilroy 2004). Rather than replacing one concept with the other, the fourteen contributors to this book seek to explore the interconnections – commonalities and differences – between them, suggesting that creolisation is a necessary complement to the already-intertwined concepts of conviviality and cosmopolitanism. Although this volume takes northern Europe as its focus, the contributors take care to put each situation in historical and global contexts in the interests of moving beyond the binary thinking that prevails in terms of methodologies, analytical concepts, and political implementations