Methods | Six-week randomised, double-blind, multicentre study. | |
Participants | In- and outpatients fulfilling ICD-10 criteria for depressive episode, recurrent depressive disorder, or bipolar affective disorder (depressive), with a score of at least 25 on the MADRS, requiring an antidepressant treatment. Age range: 18-65 years old. Exclusion criteria: severe risk of suicide, acute or chronic psychosis, failure to respond to 2 antidepressants for the current depressive episode, previous history of drug abuse or dependence, severe somatic diseases in evolution, current treatment with barbiturate, buspirone, anti-epilectic drugs, use of diazepam, lorazepam and alprazolam |
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Interventions | Fluoxetine: 196 participants. Tianeptine: 191 participants. Fluoxetine dose: 20 mg/day. Tianeptine dose: 37.5 mg/day. |
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Outcomes | Primary outcome: MADRS global score. Secondary outcome: decrease of at least 50% in MADRS global score (responder patients) and CGI scores |
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Notes | Funding: unclear | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |