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. 2020 May 11;2020(5):CD003689. doi: 10.1002/14651858.CD003689.pub4

Xu 2006.

Study characteristics
Methods Study design: parallel design
Number of arms: 2
Experimental arm: paroxetine (SSRI)
Control arm: matched placebo
Participants Geographical location: China
Setting: inpatient
Stroke criteria: haemorrhagic cerebrovascular disease
Method of stroke diagnosis: met the criteria of the Fourth National Symposium on Cerebrovascular Disease in 1995 and confirmation by brain CT or MRI
Time since stroke: within 3 days
Inclusion criteria: 1) < 75 years old; 2) no cognitive impairment affecting communication; 3) no hepatic or renal impairment; 4) stroke onset is within 3 days
Exclusion criteria: 1) history of psychiatry illness
Depression criteria: meeting the diagnostic criteria of DSM‐IV
Total number randomised in this trial: 64
Number randomised to treatment group: 32 (53.1% men, mean age 65, SD 12)
Number randomised to control group: 32 (50% men, mean age 63, SD 11)
Total number included in final analysis: 57
Number included in treatment group for final analysis: 28
Number included in control group for final analysis: 29
Interventions Treatment: paroxetine (SSRI) 20 mg/day
Control: matched placebo
Treatment duration: 12 weeks
Follow‐up: not reported
Outcomes Primary outcomes
  • Depression measured using the DSM‐IV


Secondary outcomes
  • Disability measured using the MBI

  • Impairment measures using the Modified Edinburgh Stroke Scale (MESS)

Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comments: method of sequence generation not reported
Allocation concealment (selection bias) Unclear risk Comments: method of allocation concealment not reported
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Comments: blinding of participants and personnel not reported
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Comments: blinding of outcome assessors not reported
Incomplete outcome data (attrition bias)
All outcomes Unclear risk Comments: ITT analysis reported but 7/64 dropped out, how missing data were handled was not reported
Selective reporting (reporting bias) Unclear risk Comments: no trial protocol available to compare with the publication
Other bias Low risk Comments: no differences in age, gender, Modified Edinburgh Stroke Scale or ADL scales

*: control group numbers and values halved to enable comparison with each active intervention

^: results for attention control and control group pooled

ADL: activities of daily living

BDI: Beck Depression Inventory

BI: Barthel Index

BOP: Beoordelingsschaal voor Oudere Patiënten (also known as Behavioural Rating Scale)

CES‐D: Center for Epidemiologic Studies‐Depression scale

CGI: Clinical Global Impression of Depression

CT: computed tomography

CVA: cerebrovascular accident

DSM‐IV: Diagnostic and Statistical Manual of Mental Disorders‐ Fourth Edition

FIM: Functional Independence Measure

GDS: Geriatric Depression Scale

GHQ‐28: 28‐item General Health Questionnaire

HADS: Hospital Anxiety and Depression Scale

HDRS: Hamilton Depression Rating Scale

HSS: Hemispheric Stroke Scale

ICD‐10: International Classification of Diseases, Tenth Revision

IM: intramuscular

ITT: intention‐to‐treat

IQR: interquartile range

MADRS: Montgomery–Åsberg Depression Rating Scale

MBI: Modified Barthel Index

MCA: middle cerebral artery

mRS: modified Rankin Scale

MMSE: Mini Mental State Examination

MRI: magnetic resonance imaging

PHQ‐9: 9‐item Patient Health Questionaire

QoL: quality of life

RS: Rankin Scale

SD: standard deviation

SE: standard error

SNRI: serotonin and norepinephrine reuptake inhibitors

SSRI: selective serotonin reuptake inhibitors

TIA: transient ischaemic attack

ZDS: Zung Depression Scale