Li 2008.
| Study characteristics | ||
| Methods | Parallel trial, 3 (fluoxetine versus "free and easy wandering" versus placebo), we are using the fluoxetine versus placebo comparison in this review | |
| Participants | Country: China Setting: unclear Stroke criteria: by neuroimaging, ischaemic or PICH Depression diagnosis: "each patient was evaluated by a psychiatrist", HAMD > 20 included Fluoxetine group: 60 people, mean age 69.2 ± 3.5 years, men 41.6% Control: 30 people, mean age 67.8 ± 3.9 years, men 56.7% Excluded psychiatric illness other than depression, antidepressants within previous 2 weeks, MMSE < 23, severe aphasia |
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| Interventions | Treatment: fluoxetine 20 to 40 mg daily Control: placebo Duration of treatment: 8 weeks Duration of follow‐up (treatment end to study end): 0 |
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| Outcomes | HAMD BI Description of why participants left the trial early AEs (reported by participant or observed/elicited by physician at each visit) |
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| Funding source | Funded by the Natural Science Foundation of Shandong Province, People's Republic of China. None of authors had financial ties with the companies producing the medications in this study | |
| Notes | Note twice as many in fluoxetine as in control group Study conducted between March 2006 to September 2007. None of the authors or departments involved in the study had financial ties with the companies producing the medications used in this study |
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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) | Unclear risk | Unclear |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Paper states blinded, used placebo (though unclear if matching, thus unclear (had a matching placebo been used then it would have been low) |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 4/90 dropped out (< 5%) |
| Selective reporting (reporting bias) | Unclear risk | No protocol |
| Other bias | Low risk | Balanced baseline |