Almeida 2006.

Study characteristics
Methods	Study design: randomised (2‐arm parallel randomised controlled clinical trial) Sample size: 981 Method of randomisation: block randomisation Method of concealment: centralised Blinding: double‐blind Analysis: intention‐to‐treat Date the study was conducted: June 2002 ‐ June 2004
Participants	Location: Australia Total N randomised: 111 Intervention n: 55 (67 % male; age M = 68, SD = 13; haemorrhagic stroke n = 7, Ischaemic stroke n = 104) Control n: 56 (63 % male; age M = 67, SD = 13) Inclusion criteria: acute Ischaemic or haemorrhagic stroke and no depression at baseline Diagnostic criteria ‐ long‐term physical condition: acute Ischaemic or haemorrhagic stroke diagnosed according to ICD‐10 Diagnostic criteria ‐ depression: depression is assessed by the HADS ‐ depression sub scale [HADS‐D] (a cut‐off score > 7 implies depression) Exclusion criteria: alcohol dependence; severe communication difficulties (aphasia or limited ability to communicate in English); unstable medical condition as determined by the treating physician; severe cognitive impairment (Mini‐Mental State Examination [MMSE] score ≤ 10); and depression (HADS‐D score > 7); taking· antidepressants (within 4 weeks of stroke); prior history of clinically significant adverse reactions to sertraline History of depression: no information specified
Interventions	Intervention: sertraline: fixed daily dose of 50 mg at night Control: matched placebo Other treatment: intervention/placebo: within a period up to 2 weeks after stroke symptoms became apparent Duration of treatment: 24 weeks Length of follow‐up: 52 weeks after randomisation (at baseline, 12, 24, 36 and 52 weeks) Other study arms: No
Outcomes	Primary outcome: incidence of depression ‐ diagnosis: diagnosis by the treating physician at 24 or 52 weeks (prescription of an antidepressant) adverse events: total number of adverse events (at 12 or 24 weeks) Secondary outcome: incidence of depression ‐ cut‐off: HADS‐D cut‐off score ≥ 8 (at 24 or 52 weeks) severity of depression: HADS‐D (at 24 or 52 weeks) cost‐effectiveness: N/A cost‐utility: N/A
Notes	Language: English Funding: Unrestricted grant from the Rotary Health Research Fund of Australia, Parramatta, Australia. No other financial affiliation is relevant to the subject of this article. Declaration of interest: No other financial affiliation is relevant to the subject of this article.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"subjects were allocated ... according to a computer‐generated random Iist of numbers..." (P. 1105) "the lists were produced in random blocks of 8, 10, or 12 subjects to minimize the risk of unbalanced treatment groups and nonblinding" (P. 1105)
Allocation concealment (selection bias)	Low risk	"...according to a computer‐generated random Iist of numbers that was maintained centrally and independently by the pharmacist of the Royal Perth Hospital..." (P. 1105)
Blinding of participants and personnel (performance bias) All outcomes	Low risk	both the research team and participants were unaware of treatment allocation until the final endpoint was collected from the last participant enrolled into the study. (P. 1105)
Blinding of outcome assessment (detection bias) All outcomes	Low risk	both the research team and participants were unaware of treatment allocation until the final endpoint was collected from the last participant enrolled into the study. (P. 1105)
Incomplete outcome data (attrition bias) All outcomes	High risk	numbers randomised: sertraline: n = 55; placebo: n = 56; total: n = 111 number of drop‐outs at week 24: n = 12, no further information specified number of drop‐outs at week 52: sertraline: n = 11; placebo: n = 6; total: n = 17 numbers analysed post‐intervention: sertraline: n = 48; placebo: n = 51; total: n = 99 numbers analysed follow‐up: sertraline: n = 44; placebo: n = 50; total: n = 94 reasons for drop‐out: no further information specified
Selective reporting (reporting bias)	Unclear risk	no protocol available
Other bias	Low risk	"only I breach of protocol was recorded: treatment allocation was disclosed upon request from the treating physician and Ethics Committee after a participant developed seizures. Treatment was discontinued at the end of week 24." (P. 1105)