Zhou 2008.
| 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 livingAE: adverse events; AE: adverse event; 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; EEG: electroencephalogram; 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; MMSE: Mini‐Mental State Examination; 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; 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; SSS: Scandinavian Stroke Scale; TESS: Treatment Emergent Symptom Scale; TIA: transient ischaemic attack; WHO: World Health Organization