Burns 1999.

Methods	Parallel design Analysis: ITT: 2 withdrawn and 1 death (treatment), 1 death (placebo), last value carried forward
Participants	Diagnosis: stroke. Months from stroke: median (range) 10.5 months (1 ± 156) in sertraline group and 5.5 months (1.5 ± 48) in the control group Treatment: 14 people Control: 14 people Exclusion criteria: less than 1 month since stroke, depression or dementia using the DSM III‐R criteria
Interventions	Treatment: sertraline 50 mg daily Control: matched placebo Duration: treatment continued for 8 weeks Duration of follow‐up: 2 weeks off treatment. All scores became non‐significant (though data not reported so could not be used in the analysis)
Outcomes	Able to use: improved score on lability scale improved score on clinician's interview based impression of change diminished tearfulness leaving the study early death AEs Method of collecting AEs was not stated Unable to use: MADRS, BI, MMSE (data not presented)
Funding source	Funded by an unrestricted personal grant from Pfizer, the manufacturers of sertraline
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)	Low risk	Blocks of 4 using list produced by medical statistics department
Allocation concealment (selection bias)	Unclear risk	Not stated
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Matched placebo
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Run‐out was single‐blind, treatment was double‐blind, but unclear whether outcome assessors were blind
Incomplete outcome data (attrition bias) All outcomes	Low risk	Analysis: ITT, LOCF
Selective reporting (reporting bias)	Low risk	Trial details published on www.strokecentre.org/trials, although unable to use data from MADRS Given that the main aim was to explore effect on emotionalism, this is unlikely to have biased results
Other bias	Unclear risk	Placebo group younger, uncertain influence on bias Statistical analysis was carried out independently by the Applied Statistics Research Unit in Canterbury