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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 two-centre study.
Participants Outpatients fulfilling DSM-III-R criteria for major depressive episode, with a score of at least 18 on the HDRS-21.
Age range: 18-75 years old.
Exclusion criteria: pregnancy, lactation, severe coexisting disease, unstable diabetes, organic brain syndrome, history of alcohol or drug abuse, schizophrenia or psychosis, severe risk of suicide
Interventions Fluoxetine: 61 participants.
Paroxetine: 60 participants.
Fluoxetine dose: 20 mg/day.
Paroxetine dose: 20 mg/day.
Outcomes Primary outcome: change from baseline on the HDRS total score at endpoint.
Secondary outcomes: change from baseline in the Hamilton sub-factor scores (anxiety, retardation, sleep disturbance, melancholia, recognition), proportion of patients responding to treatment, change from baseline on the CGI-S and CGI-I
Notes Response: decrease of at least 50% in the HDRS total score.
Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear