Almeida 2006.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Treatment arm: sertraline (SSRI) Control arm: matched placebo |
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Participants | Geographical location: Australia
Setting: inpatient
Stroke criteria: acute ischaemic or haemorrhagic stroke Method of stroke diagnosis: via clinical signs (ICD‐10) and CT (100% imaged, 10/111 CT scan did not show acute ischaemia) Time since stroke: stroke on average < 2 weeks prior to randomisation Inclusion criteria: not reported Exclusion criteria: 1) severe communication difficulties; 2) unstable medical condition; 3) severe cognitive impairment and depression; 4) taking antidepressants within 4 weeks of stroke; 5) contraindication to sertraline Depression criteria: HADS score > 8 Total number randomised in this trial: 111 Number randomised to treatment group: 55 (67% men, mean age 68 years, SD 13) Number randomised to control group: 56 (62% men, mean age 67 years, SD 13) Total number included in the final analysis: 99 Number included in treatment group for final analysis: 48 Number included in control group for final analysis: 51 |
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Interventions | Treatment: sertraline (SSRI), 50 mg, daily (night)
Control: matched placebo
Treatment duration: treatment continued for 24 weeks Follow‐up: 28 weeks post treatment end (52 weeks from baseline) |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Subjects were allocated to 24‐week treatment with placebo or sertraline (fixed daily dose of 50mg at night) according to a computer‐generated random list of numbers ..." pp. 1105 |
Allocation concealment (selection bias) | Low risk | Quote: "Placebo and sertraline were delivered in capsules that had the same size, shape, colour, smell, and weight" pp. 1105 |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Both the research team and participants were unaware of treatment allocation …" pp. 1105 |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "We designed this randomized, double‐blind, placebo control trial ..." pp. 1105 |
Incomplete outcome data (attrition bias) All outcomes | High risk |
Quote: "... last observation carried forward (LOCF) analyses to investigate the primary endpoint of interest for this study ..." pp. 1106 Comments: per protocol analysis presented. 11/111 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: more participants in treatment group with previous heart attack and stroke, also higher levels of hypertension |