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. 2021 Nov 15;2021(11):CD009286. doi: 10.1002/14651858.CD009286.pub4

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
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
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
Outcomes HAMD
Neurological function impairment score
BI
AEs not recorded
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