Tsai 2011.
Study characteristics | ||
Methods | Study design: parallel design Number of arms: 2 Experimental arm: milnacipran (SNRI) Control arm: matching placebo | |
Participants | Geographical location: Taiwan
Setting: inpatient
Stroke criteria: first ischaemic or recurrent stroke Method of stroke diagnosis: confirmed by imaging Time since stroke: 4 weeks before admission Inclusion criteria: 1) first or recurrent ischaemic stroke Exclusion criteria: 1) with past history of depression, substance abuse or psychosis; 2) taking antidepressants at least two weeks before stroke; 3) MMSE <15; 4) impairment of communication; 5) TIA; 6) had possible concurrent depression (HDRS > 10). Depression criteria: HDRS > 10 Total number randomised in this trial: 92 Number randomised to treatment group: 46 (65.2% men, mean age 61.0, SD 10.8) Number randomised to control group: 46 (63% men, mean age 64.9, SD 10.5) Total number included in final analysis: 56 Number included in treatment group for final analysis: 25 Number included in control group for final analysis: 31 |
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Interventions | Treatment: milnacipran (SNRI), 50 mg/day titrated to 100 mg/day
Control: matching placebo
Treatment duration: 12 months Follow‐up: not reported |
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Outcomes | Primary outcomes
Secondary outcomes
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "The randomization was carried out by our pharmacy department, which has a professional team in charge of the clinical drug trials in our hospital." pp. 264 Comments: method of sequence generation not reported |
Allocation concealment (selection bias) | Low risk | Quote: "They prepared the drug with an allocation number for each participant based on their random assignment." pp. 264 |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The placebo was tailor‐made, and the appearance and weight (starch inside) were the same as that of the active drug, milnacipran." pp. 265 |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "All the interviewers were blinded to the patient’s medication." pp. 265 |
Incomplete outcome data (attrition bias) All outcomes | Low risk |
Quote: "Fifty‐six (60.9%) of 92 patients completed 12 months of study treatment: 25 (54.3%) of 46 in the treatment group and 31 (67.4%) of 46 in the placebo group, respectively." pp. 265 Comments: Figure 1 and Table 1 presents ITT analysis. All 92 participants were included in the analysis |
Selective reporting (reporting bias) | Low risk | Quote: "The modified version of the 17‐item HDRS without item 14 (sexual behavior), NIHSS, and BI, were assessed in each of the follow‐up visits. The definition of PSD in the study was based on the diagnostic criteria of major depressive episode in DSM‐IV by professional psychiatrists." |
Other bias | Unclear risk | Comments: treatment group appears to contain higher proportion of participants who have higher than secondary school education 34.8% compared to 20.0% |