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. 2019 Nov 26;2019(11):CD009286. doi: 10.1002/14651858.CD009286.pub3

Zhao 2011.

Methods Study type: interventional (clinical trial)
Primary purpose: treatment
Participants Country: People's Republic of China
Setting: inpatient
At randomisation number allocated: N = 82: fluoxetine (n = 41); placebo (n = 41)
% male: 58.5
Age: mean age 65 ± 12
Subtype of stroke: Ischaemic stroke: 61/82 (74%); haemorrhagic stroke: 21/82 (26%)
Severity of stroke: MESSS: fluoxetine 23.2 ± 6.2 (n = 37); placebo 22.8 ± 5.8 (n = 34)
Time since stroke onset: within 10 days
Inclusion criteria:

  • Consistent with the Diagnostic Criteria for Cerebrovascular Disease formulated by the Fourth National Conference of Chinese Medical Association in 1995, and prove with brain CT or MRI

  • Obvious aphasia and unable to communicate normally after language function evaluation

  • Age 75 years old or less

  • Without previous psychiatric illness

  • No severe cognitive impairment


Exclusion criteria: none
Withdrawal criteria: not stated
Interventions Experimental:fluoxetine 20 mg daily for 12 weeks
Comparator: no fluoxetine
Outcomes Outcomes collected at 2nd, 4th and 12 week of treatment and 12 weeks after the end of treatment

  • Severity of stroke (MESSS)

  • Performance in ADLs
Funding source Not available
Notes Dates study conducted: 2008 to 2010
Declarations of Interest: none reported
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The participants were randomised into 2 groups (with fluoxetine or without fluoxetine) according to the sequence number and a block randomisation table
Allocation concealment (selection bias) Unclear risk Insufficient information to permit judgement of yes or no
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Insufficient information to permit judgement of yes or no
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Insufficient information to permit judgement of yes or no
Incomplete outcome data (attrition bias) 
 All outcomes High risk Attrition rate of fluoxetine group vs control group was 4/41 (9.8%) vs 7/41 (17.1%)
> 5% loss to follow‐up
Selective reporting (reporting bias) Unclear risk No trial protocol available. Insufficient information to permit judgement of yes or no
Other bias Low risk The study appears to be free from other sources of bias