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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, multicentre study.
Participants Outpatients suffering from a major depressive episode according to DSM-III-R, with a baseline score on HDRS-17 of at least 18, recruited from nine separated psychiatric clinics.
Age range: 18 years or more.
Exclusion criteria: depression secondary to other conditions, concomitant illness of renal, cardiac or hepatic origin; hypersensitivity to other antidepressants, likelihood of poor compliance, risk of suicide, peptic ulcer history, an improvement of greater than 25% in the HDRS score during a pre-treatment placebo washout period
Interventions Fluoxetine: 56 participants.
Sertraline: 52 participants.
Fluoxetine dose range: 20-60 mg/day.
Sertraline dose range: 50-150 mg/day.
Benzodiazepines were allowed for hypnotic use and as maintenance treatment for pre-existing anxiety
Outcomes Hamilton Rating Scale for Depression (HDRS) and for Anxiety (HAM-A), Montgomery and Asberg Scale for Depression (MADRS), Zung Self-Rating Scale for Anxiety, Leeds Sleep Evaluation Questionnaire, Clinical Global Impression Scale, including severity (CGI-S) and improvement (CGI-I)
Notes 75% of the patients were women. Higher percentage of patients with a family history of psychiatric illness in the fluoxetine group. Higher percentage of patients with severe depression in the fluoxetine group (30.4%) than in the sertraline group (13.7%).
Funding: unclear
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear
HHS Vulnerability Disclosure