Zhou 2008.
| Study characteristics | ||
| Methods | Aim: to study effect of early paroxetine on post‐stroke depression and rehabilitation Parallel design Analysis: according to treatment groups |
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| Participants | Country: China Setting: inpatient Stroke criteria: all stroke, clinical diagnosis plus confirmation by imaging (though not clear if a relevant stroke lesion had to be visible), stroke onset time ≤ 7 days, no obvious cognitive impairment, no obvious aphasia HAMD score < 8 Treatment: 36 people, mean age 63 ± 9.3 years, 16 men Control: 40 people, mean age 61 ± 9.6 years, 19 men Excluded: previous psychiatric disorders, severe hepatic and renal impairment, taking agents with obvious interaction with fluoxetine in recent 1 month |
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| Interventions | Treatment: fluoxetine 20 mg daily plus acute stroke routine medication Control: acute stroke routine medication Duration of treatment: 8 weeks Duration of follow‐up: 0 |
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| Outcomes | No raw data provided for any of the following outcomes: diagnosis of depression (CCMD‐3, HAMD, ADL, MESSS) Reported no deaths in either group. Unclear how data on side effects were collected |
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| Funding source | Source of funding not stated | |
| Notes | − | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Method not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No placebo |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not described |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts, analysed according to allocated treatment group |
| Selective reporting (reporting bias) | High risk | No protocol, no raw data provided for several of the outcomes |
| Other bias | Low risk | Baseline similar |
ADL: activities of daily living AE: adverse event ALT: Alanine aminotransferase test BDI: Beck Depression Inventory BI: Barthel Index CCMD‐II‐R: Chinese Classification of Mental Disorders, second edition, revised CCMD‐3: Chinese Classification of Mental Disorders‐3 CGI: Clinical Global Impressions Scale CSS: Chinese Stroke Scale CT: computerised tomography CTIMP: Clinical Trial of an Investigational Medical Product DSM: Diagnostic and Statistical Manual of Mental Disorders EEG: electroencephalogram eFGR: estimated glomerular filtration rate FAI: Frenchay Activities Index FAST: Frenchay Aphasia Screening Test FIM: Functional Independence Measure FMMS: Fugl‐Meyer Motor Scale fMRI: functional magnetic resonance imaging GDS: Geriatric Depression Scale GI: gastrointestinal HADS: Hospital Anxiety and Depression Scale HAMA: Hamilton Anxiety scales HAMD/HDRS: Hamilton Depression Rating Scale HSS: Hemispheric Stroke Scale ICD: International Classification of Diseases ICH: intracerebral haemorrhage IL: interleukin ITT: intention‐to‐treat IQR: interquartile range JHFI: Johns Hopkins Functioning Inventory LOCF: last‐observation‐carried‐forward MADRS: Montgomery‐Åsberg Depression Rating Scale MAOI: mono‐amino‐oxidase inhibitor MCA: middle cerebral artery MEP: motor evoked potentials MESSS: Modified Edinburgh‐Scandinavian Stroke Scale MHI‐5: Mental Health Inventory MMSE: Mini‐Mental State Examination MoCA: Montreal Cognitive Assessment MRI: magnetic resonance imaging mRS: modified Rankin score NIHSS: National Institutes of Health Stroke Scale PASE: Physical Activity Scale for the Elderly PICH: primary intracerebral haemorrhage RCT: randomised controlled trial RS: Rankin score SAH: subarachnoid haemorrhage SAS: Zung Self‐rating Anxiety Scale SD: standard deviation SDS: Zung Self‐rating Depression Scale SF‐36: Short Form‐36 SIS: Stroke Impact Scale SSRI: selective serotonin reuptake inhibitors SSS: Scandinavian Stroke Scale TESS: Treatment Emergent Symptom Scale TIA: transient ischaemic attack VAS: visual analogue scale WHO: World Health Organization