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.

Key Clinical MessageStroke is a common embolic complication of infective endocarditis. The most important treatment to prevent stroke in endocarditis is the initiation of antibiotic therapy. It is unclear whether the initiation of de novo anticoagulation (i.e, warfarin) in patients with infective endocarditis is beneficial, since there are no large or randomized controlled trials in this area. However, this case report suggests, despite the limited evidence, that anticoagulation in this patient caused no harm and could suggest a hint of possible benefit.

Internal carotid artery [ICA] dissection is a rare cause of vocal cord palsy. This cause is not always considered in the initial differential diagnosis and such cases often get classed as idiopathic. We report a case of right ICA dissection, where the patient had presented with symptoms of right vocal cord palsy. This was a 52-year-old woman who presented to ENT department with a 3 week history of hoarse voice, sore throat and dysphagia. She was found to have a right vocal cord palsy and oropharyngeal dysphagia. Her neurological examination at the time of assessment was normal except for a mild reduced elevation of right side of her palate. At that time, the aetiology was thought to be idiopathic. Due to an incidental sphenoid wing meningioma on the CT head and neck, she underwent an MRI head, which demonstrated a thrombosed right ICA. Subsequently, her CT images were reconstructed to demonstrate a rat-tail stenosis of the lower right ICA consistent with dissection, for which she was started on clopidogrel. Therefore an internal carotid artery dissection should be considered in a case of ‘idiopathic’ vocal cord palsy, as they may not necessarily be idiopathic.