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. Author manuscript; available in PMC: 2014 Sep 15.
Published in final edited form as: Cochrane Database Syst Rev. 2005 Oct 19;(4):CD004185. doi: 10.1002/14651858.CD004185.pub2
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
Interventions Fluoxetine: 196 participants.
Tianeptine: 191 participants.
Fluoxetine dose: 20 mg/day.
Tianeptine dose: 37.5 mg/day.
Outcomes Primary outcome: MADRS global score.
Secondary outcome: decrease of at least 50% in MADRS global score (responder patients) and CGI scores
Notes Funding: unclear
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear