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 |
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Interventions | Treatment: paroxetine (SSRI) 20 mg/day
Control: matched placebo
Treatment duration: 12 weeks Follow‐up: not reported |
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Outcomes | Primary outcomes
Secondary outcomes
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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