Skip to main content
. 2019 Mar 19;2019(3):CD003690. doi: 10.1002/14651858.CD003690.pub4

Choi‐Kwon 2006.

Methods Study design: parallel design
 Number of arms: 2
Experimental arm: fluoxetine 20 mg/day
Control arm: placebo
 Analysis: intention‐to‐treat: 3 withdrawn (placebo), last value carried forward
 Per protocol was also performed to investigate the consistency of the results
Participants Geographical location: South Korea
Setting: Asan Medical Centre
Number of participants: 92
Diagnosis: stroke, time from stoke to randomisation not reported
 Inclusion criteria: not specified
Exclusion criteria: 1) did not undergo imaging (CT/MRI) studies, 2) had subarachnoid haemorrhage, 3) had transient ischaemic attack without progression to stroke, 4) had communication problems (aphasia, dementia or dysarthria) severe enough as not to undergo a reliable interview, 5) were scored < 23 on MMSE, 6) had a history of being diagnosed as having depression or other psychiatric illnesses before the onset of stroke, 7) had been already treated with psychiatric regimens including SSRI, and 8) lived alone so that information from the relatives was not available
Age: mean age not reported
Numbers of included in treatment group: 44* ‐ age and sex of participants with excessive crying not reported
Numbers of included in control group: 48* ‐ age and sex of participants with excessive crying not reported
 *Number stated is inconsistent in the report ‐ we have reported data on excessive/inappropriate crying only, as represented in Table 3 of Choi‐Kwon 2006
 Emotionalism criteria: emotionalism is present if both patients and relatives agreed that ≥ 2 occasions of excessive or inappropriate laughing or crying or both has occurred as compared with their premorbid state
Interventions Treatment: fluoxetine 20 mg/day
 Control: matched placebo
 Duration: treatment continued for 3 months
 Assessments performed at enrolment, 1 month, 3 months, and 6 months
Outcomes Primary outcomes
  • Presence poststroke depression (BDI score)

  • Intenstiy of poststroke emotional incontinence (VAS)

  • Presence of poststroke anger (Spielberger Trait Anger Scale)


Secondary outcomes
  • Percentage changes in BDI scores for poststroke depression

  • Percentage changes in VAS scores for emotional incontinence crying/laughing

  • Percentage changes in poststroke anger scores

  • Patients' subjective responses as "aggravated", "no change" and "improved"

Notes Able to use in analysis
  • Patients' subjective responses of improvement in excessive/inappropriate crying

  • Leaving the study early


Unable to use in analysis: VAS for measuring extent of excessive or inappropriate laughing or crying (data not presented in appropriate format). Percentage change of VAS between follow‐ups (number of emotionalism participants is inconsistent in report)
 Adverse events (data for emotionalism participants not stated)
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "Treatment allocation was based on a computer generated list of treatment numbers" pp.157
Allocation concealment (selection bias) Unclear risk Comments: not detailed
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "The patient, relatives and researchers were not aware of the drug being given" pp. 157
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "The patient, relatives and researchers were not aware of the drug being given" pp. 157
Incomplete outcome data (attrition bias) 
 All outcomes High risk Quote: "Among 152 patients, 27 dropped out before completing the 3‐month treatment protocol (15 received fluoxetine, and 12 received placebo), leaving 125 patients. Although there was no difference in the dropout rate between the 2 groups ..." pp. 157
Comments: number of total participants stated is inconsistent
Selective reporting (reporting bias) Low risk Comments: all prespecified outcomes reported. No trial protocol available prior to randomisation of first participant
Other bias Unclear risk Comments: no other bias detected