Li 2004a.
Study characteristics | ||
Methods | Parallel group Aim: to study effects of fluoxetine on neurological impairment and post‐stroke depression |
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Participants | Location: China Setting: inpatient Stroke: inclusion: all pathological types, clinical diagnosis plus confirmation by imaging that relevant lesion visible, CSS 16 to 30 Depression criteria: HAMD scores ≥ 17 and DSM IV diagnostic criteria Treatment: 33 people, mean age 60.33 years, 24 men Control: 34 people, mean age 60.44 years, 23 men Excluded severe psychiatric disorders, severe cardiac, pulmonary, hepatic and renal disease |
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Interventions | Treatment: fluoxetine 20 mg daily plus routine acute stroke care Control: routine acute stroke care Duration of treatment: 4 weeks Duration of follow‐up (end of treatment to end of study): 0 |
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Outcomes | CSS Depression incidence Laboratory monitoring parameters AEs (method of reporting 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) | Low risk | Computer random numbers |
Allocation concealment (selection bias) | Low risk | Opaque sealed envelopes |
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 |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Low risk | Balanced baseline |