Methods | Eight-week double-blind, randomised two-centre study. | |
Participants | Outpatients with a diagnosis of moderate to severe major depressive episode without psychotic features or bipolar disorder of the depressed type according to DSM-III-R, with a total score of least 18 points on HDRS-17 at baseline. Age range: over 18 years old. Exclusion criteria: concomitant organic mental disorder, psychoactive substance abuse disorder, schizophrenia or other psychotic disorder or any medical condition that controindicated treatment with antidepressants; pregnancy or lactating; women of childbearing popotential not practicing a reliable method of contraception |
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Interventions | Fluoxetine: 37 participants. Nefazodone: 37 participants. Fluoxetine dose range: 20-40 mg/day. Nefazodone: 400-500 mg/day. Concomitant psychotropic medication was prohibited, but occasionally use of benzodiazepines for severe anxiety or insomnia |
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Outcomes | Hamilton Rating Scale for Depression, Hamilton Rating Scale for Anxiety, Clinical Global Impression, Patient Global Assessment | |
Notes | One attempted suicide in the fluoxetine group. Funding: by industry |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |