Brown 1998.
Study characteristics | ||
Methods | Parallel design Analysis: per protocol: 1 withdrawn (treatment), excluded from analysis |
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Participants | Diagnosis: stroke, time from stroke to randomisation not reported Randomised 10 to treatment and 10 to control Treatment: 9 completed treatment, mean ± SD age 61.4 ± 8.6 years, 55% men Control: 10 people completed placebo, mean ± SD age 63.7 ± 5.4 years, 60% men Emotionalism criteria: emotionalism of at least 4 weeks' duration assessed during semi‐structured interview using a modified Lawson and MacLeod rating scale, in addition to frequency of outbursts Exclusion criteria: cognitive impairment, dysphasia, major depressive disorder |
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Interventions | Treatment: fluoxetine 20 mg daily Control: matched placebo Duration: 10 days Duration of follow‐up: (end of treatment to end of study) 0 |
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Outcomes | Used leaving the study early Unable to use data from HDRS, Lawson and MacLeod Scale, self‐rating scales (mean and SD not presented) Also reported emotional outbursts; we have not used these in our analyses AEs: not presented |
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Funding source | Funder not stated | |
Notes | Dates of study not stated; conflicts of interest not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomisation method not stated |
Allocation concealment (selection bias) | Unclear risk | Randomised by independent statistician |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | States blinding of patients and nursing staff, matched placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | States blinding of rating clinicians |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 1 withdrawn (5% of participants); we categorised this as low risk |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make judgement |
Other bias | Low risk | No other obvious biases, baseline balanced |