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Number of arms: 2 Experimental arm: fluoxetine 20 mg/day Control arm: placebo Analysis: intention‐to‐treat: 3 withdrawn (placebo), last value carried forward Per protocol was also performed to investigate the consistency of the results |
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| 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 |
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| 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
Secondary outcomes
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| Notes | Able to use in analysis
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) |
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| 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 |