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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 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
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
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
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear