Rasmussen 2003.

Study characteristics
Methods	Study design: parallel design Number of arms: 2 Experimental arm: sertraline (SSRI) Control arm: matched placebo
Participants	Geographical location: Denmark Setting: unclear Stroke criteria: ischaemic and primary intracerebral haemorrhage Method of stroke diagnosis: via clinical signs and symptoms Time since stroke: 0 to 4 weeks prior to randomisation Inclusion criteria: not reported Exclusion criteria: 1) current depression; 2) significant aphasia or dementia; 3) history of schizophrenia; 4) psychosis or severe drug abuse; 5) pre‐existing neurological illness; 6) antidepressants in preceding 4 weeks; 7) current (within 6 months) cardiovascular illness Total number randomised in this study: 137 Number randomised to treatment group: 70 (50% men, mean age 72 years, SD 9) Number randomised to control group: 67 (51% men, mean age 68 years, SD 11) Total number included in final analysis: 118 Number included in treatment group for final analysis: 61 Number included in control group for final analysis: 57
Interventions	Treatment: sertraline (SSRI), 50 mg daily; at any time after 2 weeks dose could be increased in 50 mg increments up to 150 mg daily; average dose 62.9 mg daily Control: matched placebo Treatment duration: treatment continued for 12 months Follow‐up: not reported
Outcomes	Primary outcomes Depression (change in scores from baseline to end of treatment) measured using the HDRS Depression (proportion scoring > 2) measured using the CGI Depression (proportion scoring > 16) measured using the GDS Secondary outcomes Leaving the study early
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Quote: "Patients were randomly assigned to 12 months of double‐blind study treatment." pp. 217 Comments: method of sequence generation not reported
Allocation concealment (selection bias)	Unclear risk	Comments: method of allocation concealment not reported
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: title ‐ "A double‐blind, placebo‐controlled study of sertraline in the prevention of depression in stroke patients." pp. 216 Comments: who was blinded was not reported
Blinding of outcome assessment (detection bias) All outcomes	Low risk	Quote: title ‐ "A double‐blind, placebo‐controlled study of sertraline in the prevention of depression in stroke patients." pp. 216 Comments: who was blinded was not reported
Incomplete outcome data (attrition bias) All outcomes	High risk	Comments: per protocol analysis reported only. 19/137 were not included in the analysis
Selective reporting (reporting bias)	Unclear risk	Comments: no trial protocol available to compare with the publication
Other bias	Unclear risk	Comments: the treatment group were older on average