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 MADRS and a MMSE of at least 24. Age range: over 65 years old. Exclusion criteria: |
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Interventions | Fluoxetine: 122 participants. Tianeptine: 115 participants. Fluoxetine dose: 20 mg/day. Duloxetine dose range: 20-37.5 mg/day. |
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Outcomes | Primary outcomes: change in the total score on the Montgomery and Asberg Scale for Depression (MADRS). Secondary outcomes: total number of responders at endpoint, total number of remissions at endpoint, measn variation on the Geriatric Depression Scale | |
Notes | Response: decrease of at least 50% in the MADRS total score. Remission: total score less than 10 on the MADRS. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |