Guelfi 1998a.
Methods | 12 week randomised double blind study | |
Participants | Diagnosis: Inpatients with DSM‐III‐R major depression Male and Female. Threshold of baseline severity: HDRS‐17>=22, Newcastle scale>=6, HDRS specific endogenous subscale>=8 Total number of all allocated participants: N=300 Age: mean 45.6 (SD 12.8)y for milnacipran 100mg, mean 45.2 (SD 12.5)y for milnacipran 200mg, mean 45.8 (SD 12.8)y for fluoxetine; range 18‐70y |
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Interventions | Milnacipran 100/200mg: N=200 (100mg:N=100, 200mg:N=100)
Fluoxetine 20mg: N=100 Fixed dosing schedule. |
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Outcomes | Hamilton Depression Rating Scale‐17 item, MADRS, CGI‐S | |
Notes | Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomised". Probably done. |
Allocation concealment (selection bias) | Unclear risk | Insufficient information. |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "double‐blind" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Missing primary outcome data at early phase. |
Selective reporting (reporting bias) | High risk | Some missing standard deviations. |
Other bias | Unclear risk | Insufficient information to assess whether an important risk of bias exists. |