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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 DSM-IV criteria for major depressive disorder, (single or recurrent), without psychotic features, with or without melancholia, or bipolar II disordr, current episode depressed, moderate or severe without psychotic features with or without melancholia, with a score of at least 25 on the MADRS.
Age range: 18-65 years old.
Exclusion criteria: dysthymia, cyclothymia, double-depression, psychotic disorder, drug or alcohol abuse or dependence, serious risk of suicide, treatment resistant depression, recurrent ECT, non-response to previous treatment with fluoxetine or tianeptine, severe hepatic, cardiovascular, neurological, metabolic disease, cancer or allergy, pregnancy, previous treatment with neuroleptics in the previous 2 months, MAOI, fluoxetine lithium, valpromide or carbamazepine within 1 month of baseline, other antidepressants, diazepam, lorazepam, alprazepam, bromazepam, barbiturates, buspirone the week before recruitment
Interventions Fluoxetine: 91 participants.
Tianeptine: 87 participants.
Fluoxetine dose: 20 mg/day.
Tianeptine dose: 37.5 mg/day.
Chloralzepate (max 30 mg), oxazepam (max 60 mg) for anxiety and nitrazepam (1 mg) or lorazepam (1 mg) for insomnia. For patients who were usually taking benzodiazepines for at least 1 month before
baseline continuation during the trial was allowed
Outcomes Primary outcome: Montgomery and Asberg Scale for Depression
Notes Response: decrease of at least 50% in the MADRS total score.
Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear
HHS Vulnerability Disclosure