Wang 2003.
Study characteristics | ||
Methods | Parallel design 3‐arm trial: routine care, fluoxetine plus routine care, amitriptyline plus routine care. We are using the routine care and fluoxetine plus routine care in this analysis Aim: to observe effects of antidepressant therapy on post‐stroke and neurological rehabilitation in the elderly |
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Participants | Country: China Setting: inpatient Stroke criteria: ischaemic stroke, clinical diagnosis plus confirmation by imaging (although not clear whether a stroke lesion had to be present) Depression diagnosed according to CCMD‐II‐R diagnostic criteria, HAMD ≥ 18 Treatment: 64 people, mean age 75.6 ± 19.7 years, 39 men Control: 56 people, mean age 74.9 ± 20.8 years, 29 men Excluded: psychiatric disorder history, severe cardiac, pulmonary, hepatic and renal diseases |
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Interventions | Treatment: fluoxetine 20 mg to 80 mg daily (start at 20 mg/day, increase dosage at 3 weeks if poor therapeutic effect and no AE), plus usual stroke care Control: usual stroke care Duration of treatment: 12 to 24 weeks Duration of follow‐up (treatment end to study end): 6 to 9 months |
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Outcomes | HAMD Neurological function impairment score BI AEs not recorded |
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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 | Method not described |
Allocation concealment (selection bias) | Unclear risk | Not described |
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 | High risk | 13 dropped out of fluoxetine group, and 9 dropped out of control group |
Selective reporting (reporting bias) | Unclear risk | No protocol |
Other bias | Unclear risk | Baseline appeared balanced but no statistical comparison between groups |