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

Ye 2004.

Study characteristics
Methods Aim: to investigate whether antidepressive therapy is needed for people with post‐stroke depression or not, and the effect of different antidepressive drugs on the rehabilitation of psychological and neurological function after stroke
3 groups: paroxetine, imipramine and control. We are using the paroxetine versus control arm in this review
Participants Country: China
Setting: inpatient
Stroke: all pathological subtypes, clinical diagnosis plus confirmation by imaging (did not state whether a visible lesion was needed to make the diagnosis), no positive psychiatric disorders or family history, clear consciousness, no comprehension problem
Mood: inclusion criteria: HAMD score > 21, HAMA scale > 14
Treatment: 30 people, age 58.04 ± 8.28 years, 22 men
Control: 30 people, age 59.21 ± 9.52 years, 17 men
Exclusion criteria: severe cardiac, hepatic and renal diseases, multiple infarcts or haemorrhage
Interventions Treatment: paroxetine 20 mg/day plus acute stroke routine care and rehabilitation
Control: acute stroke routine care plus rehabilitation
Duration of treatment: 12 weeks
Duration of follow‐up (end of treatment to end of study): 0
Outcomes Chinese Neurological Impairment Scale, modified BI, HAMD, HAMA, Therapeutic Effect for Depression and Neurologic Function
Death, GI upset
Method of recording side effects not stated
Funding source Source of funding not stated
Notes Inconsistent description about the number of recruitment and randomisation between abstract (N = 90) and result part (N = 93) of the text. The number for final analysis is consistent in the text
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Used "number table", but unclear if this was a random number table
Allocation concealment (selection bias) Low risk The study designer was not involved in assessment and treatment, the assessors did not know the allocation
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk The participants were blinded. Not clear if those delivering the treatment were blind, but no placebo used
Blinding of outcome assessment (detection bias)
All outcomes Low risk Assessors were blinded
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Only 1 dropped out in paroxetine group
Selective reporting (reporting bias) Unclear risk No protocol
Other bias Unclear risk Different numbers reported to have been recruited and randomised, baseline similar