Song 2006.
Study characteristics | ||
Methods | Aim: to evaluate changes in depression and cognitive impairment in people with post‐stroke depression treated with fluoxetine Parallel trial |
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Participants | Country: China Setting: inpatient Stroke diagnosed by clinical criteria and "proved on CT" (though not clear if lesion had to be visible) Depression: diagnosed in accordance with the CCMD‐II‐R Treatment: 41 people, mean age 51 ± 7 years, 25 men), time since stroke: 3.5 days Control: 41 people, mean age 50 ± 8 years, 24 men), time since stroke: 3.7 days Excluded: previous mental disorders, previous "neurological disorder", if other psychiatric drugs had been taken, these had to be stopped for 1 week before fluoxetine was administered |
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Interventions | Treatment: fluoxetine 20 mg daily Control: placebo (although not stated whether this was identical to fluoxetine) Duration of treatment: 6 weeks Duration of follow‐up (treatment end to study end): 0 Side effects not reported |
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Outcomes | SDS P300 (an event‐related potential) Although the stated aim was to assess cognitive impairment, it is not clear how this was measured |
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Funding source | Source of funding not stated | |
Notes | Recruitment: December 1999 to June 2003. Conflicts of interest not stated | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Placebo, but not clear whether identical |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Unclear risk | Unclear |
Other bias | Unclear risk | Balanced baseline |