Cheng 2003
| Methods | Parallel design Aim: to treat depression and augment rehabilitation Randomisation: not stated Allocation concealment: not described Blinding: not described Analysis: according to allocated treatment group Drop‐outs: none |
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| Participants | Location: China Setting: inpatient Treatment: 25 people Control: 32 people Whole group (including non‐depression group, depression control group and depression treatment group): 132 (mean age 62 ± 12 years, 79 men) Stroke: ischaemic stroke or PICH, clinical diagnosis plus confirmation on brain imaging (not clear that a stroke lesion had to be present), clear consciousness Depression diagnosis (at 2 weeks after stroke onset): psychiatric interview, DSM IV criteria |
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| Interventions | Treatment: fluoxetine 20 mg daily Control: no fluoxetine Duration of treatment: 6 months Duration of follow‐up (post‐treatment to study end): 6 months |
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| Outcomes | SSS ADL HAMD Zung SDS Zung SAS No deaths, none left trial early No data on AEs |
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| Notes | Excluded: major psychological trauma history in previous 1 year, severe mental retardation, severe impairment of lingual expression or comprehension, major complicated medical event in previous 1 year | |
| 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 |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 59 patients were diagnosed to have depression by symptoms but only 57 were included in the results table |
| Selective reporting (reporting bias) | High risk | No protocol, no report of the results of the self rating anxiety scale |
| Other bias | Unclear risk | No clear description of differences between the treatment and control group. No description of funding |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |