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 |
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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 |
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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 |
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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 |
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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 |