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 |
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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 |
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Outcomes | Primary outcome: Montgomery and Asberg Scale for Depression | |
Notes | Response: decrease of at least 50% in the MADRS total score. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |