SummaryBackgroundResults of small trials indicate that fluoxetine might improve functional outcomes after stroke. The FOCUS trial aimed to provide a precise estimate of these effects.MethodsFOCUS 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.FindingsBetween 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.InterpretationFluoxetine 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.FundingUK Stroke Association and NIHR Health Technology Assessment Programme.

The purpose of this investigation was to examine the effects of the combination of chronic ankle instability (CAI) and altered visual focus on strategies for dynamic stability during a drop-jump task. Nineteen participants with self-reported CAI and 19 healthy participants performed a drop-jump task in looking-up and looking-down conditions. For the looking-up condition, participants looked up and read a random number that flashed on a computer monitor. For the looking-down condition, participants focused their vision on the force plate. Sagittal- and frontal-plane kinematics in the hip, knee and ankle were calculated at the time points of 100 ms pre-initial foot contact to ground and at IC. The resultant vector time to stabilisation was calculated with ground reaction force data. The CAI group demonstrated less hip flexion at the point of 100 ms pre-initial contact (P < 0.01), and less hip flexion (P = 0.03) and knee flexion at initial contact (P = 0.047) compared to controls. No differences in kinematics or dynamic stability were observed in either looking-up or looking-down conditions (P > 0.05). Altered visual focus did not influence movement patterns during the drop-jump task, but the presence of CAI did. The current data suggests that centrally mediated changes associated with CAI may lead to global alterations in the sensorimotor control.