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. 2012 Nov 14;2012(11):CD009286. doi: 10.1002/14651858.CD009286.pub2

Almeida 2006

Methods Parallel design
Randomisation: computer‐generated random list of numbers
Allocation concealment: centralised
Blinding: double blind: participants: yes; investigators: yes; outcome assessors: unknown
Analysis: ITT (last observation carried forward), withdrawn owing to becoming depressed, AE, treating practitioner started antidepressant, medical advice, no reason given, not contactable ‐ numbers not included
Participants Location: Australia
Setting: inpatient
Treatment: 55 people, mean ± SD age 68 ± 13 years, 67% men
Control: 56 people, mean ± SD age 67 ± 13 years, 62% men
Stroke criteria: acute ischaemic or haemorrhagic stroke, diagnosis by clinical signs (ICD‐10) and CT (100% imaged, 10/111 CT scan did not show acute ischaemia); stroke on average < 2 weeks prior to randomisation
Not depressed (HADS‐D had to be over 7)
Other entry criteria: not stated
Comparability of treatment groups: more participants in treatment group with previous heart attack and stroke, also higher levels of hypertension
Interventions Treatment: sertraline 50 mg daily (night)
Control: matched placebo
Duration: treatment continued for 24 weeks
Duration of follow‐up (post treatment to study end): 28 weeks
Outcomes Depression: change in scores from baseline to end of treatment on HDRS, proportion depressed
Change in MMSE scores
mRS
Death
Leaving the trial early
Check list of possible AEs read out to patient by a research nurse
Notes Exclusion criteria: severe communication difficulties, unstable medical condition, severe cognitive impairment and depression (MMSE < 10), taking antidepressants within 4 weeks of stroke, contraindication to sertraline, previous reaction to sertraline, could not speak English
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated random numbers
Allocation concealment (selection bias) Low risk Centralised
Incomplete outcome data (attrition bias) All outcomes Low risk Performed last observation carried forward
Selective reporting (reporting bias) Low risk Trial protocol published on www.strokecentre.org/trials
Other bias Low risk No other obvious biases
Funded by an unrestricted grant from Rotary Health Research Fund
Blinding of participants and personnel (performance bias) All outcomes Low risk Stated in paper, matched placebo
Blinding of outcome assessment (detection bias) All outcomes Unclear risk Not stated in paper