Almeida 2006.
| Methods | Parallel design Analysis: ITT (last observation carried forward), withdrawn owing to becoming depressed, AE, treating practitioner started antidepressant, medical advice, no reason given, not contactable ‐ numbers not included |
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| 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 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 |
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| 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 |
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| 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 participant by a research nurse |
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| Funding source | Funded by an unrestricted grant from Rotary Health Research Fund | |
| Notes | Recruitment June 2004 to June 2006 Conflicts of interest not stated |
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| 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 |
| 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 |
| 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 |