Jia 2005.
Methods | Parallel design Aim: to determine the effect of early intervention for post stroke depression on movement after 3 months of stroke |
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Participants | Country: China Setting: inpatient Inclusion: aged 40 to 75 years, all pathological types of stroke, clinical diagnosis plus confirmation by imaging (did not state whether a relevant lesion had to be present to make a diagnosis), able to give informed consent Depression diagnosis: Zung SDS > 41 for screening for depression, HDRS for evaluation of the depression severity level Treatment: 92 people randomised, 90 accepted allocation, mean age 55.6 ± 6.5 years, 60 men Control: 92 people randomised, 90 accepted allocation, mean age 55.1 ± 6.8, 55 men Excluded: organic psychiatric disorders such as Alzheimer's disease or degenerative disease, functional disorders such as schizophrenia and affective disorders |
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Interventions | Treatment: either fluoxetine or sertraline (given sertraline if also had anxiety) plus routine stroke care Control: routine stroke care Duration of treatment: 3 months Duration of follow‐up: 3 years but the authors did not describe the extent of neurological function damage and HAMD scores in the third year |
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Outcomes | HAMD Extent of neurological damage Recurrent stroke Death Did not report AEs |
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Funding source | Source of funding not stated | |
Notes | − | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Dropouts: 6 in treatment group (2 refused allocation), 4 in control group (2 refused allocation) |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Unclear risk | Balanced baseline |