Guelfi 1999.
Methods | Twelve‐week randomised, double‐blind, multicentre study | |
Participants | Outpatients (general practice) fulfilling DSM‐III‐R criteria for major depressive episode, with a score of at least 25 on the Montgomery and Asberg Scale for Depression (MADRS) and a Mini Mental State Examination (MMSE) of at least 24. Age: over 65 years Exclusion criteria: not stated | |
Interventions | Fluoxetine: 122 participants Tianeptine: 115 participants Fluoxetine dose: 20 mg/day Tianeptine dose range: 20‐37.5 mg/day | |
Outcomes | Primary outcome: change in the total score on the MADRS Secondary outcomes: total number of responders at endpoint, total number of remissions at endpoint, mean variation on the Geriatric Depression Scale (GDS) |
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Notes | Response: decrease of at least 50% in the MADRS total score Remission: total score less than 10 on the MADRS Funding: by industry | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "deux groupes de traitment ont été constitués par tirage au sorte", randomised, no further information |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Double blind, no further information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Double blind, no further information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Double blind, no further information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Mean endpoint scores reported with denominators. Dropouts reported with reasons |
Selective reporting (reporting bias) | Low risk | Side effects reported |
Other bias | High risk | Author's affiliation was Eli Lilly and this company produces fluoxetine |