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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

Brown 1998.

Study characteristics
Methods Parallel design
Analysis: per protocol: 1 withdrawn (treatment), excluded from analysis
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
Interventions Treatment: fluoxetine 20 mg daily
Control: matched placebo
Duration: 10 days
Duration of follow‐up: (end of treatment to end of study) 0
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
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All outcomes Low risk Only 1 withdrawn (5% of participants); we categorised this as low risk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