Miao 2004.
Methods | Parallel group 9 not allocated (5 in treatment group refused allocation, 4 in the control group refused allocation) |
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Participants | Country: China Setting: mixed inpatient and outpatient All stroke pathological types, clinical diagnosis plus confirmation by imaging that a relevant lesion was visible, 2 to 8 months after stroke, clear consciousness, no comprehension problem, 1 lesion in 1 hemisphere, normal language comprehension Mood: depression after stroke onset, HAMD score ≥ 20 Participants: 90 randomised, 34 in each group at treatment end Treatment: 34 people, age 58.16 ± 8.49 years, 19 men Control: 34 people, age 62.45 ± 8.24 years, 18 men Exclusion criteria: other organic brain disorders and other aetiologies‐related depression |
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Interventions | Treatment: citalopram 20 mg daily plus usual stroke care Control: usual stroke care Duration of treatment: 6 weeks Duration of follow‐up (treatment end to study end): 0 |
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Outcomes | HAMD SDS Efficacy Death AEs (only in the citalopram group) Method of recording AEs was not stated |
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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 | Quote: "Simple random sampling" Comment: no further description given |
Allocation concealment (selection bias) | Unclear risk | Allocation not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinding described |
Incomplete outcome data (attrition bias) All outcomes | High risk | 9 not allocated after randomisation, 13 dropouts |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Unclear risk | Baseline balanced |