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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 Twenty-six-week double-blind, randomised, multicentre study.
Participants Outpatients (primary care) fulfilling DSM-IV criteria for major depressive disorder, with a MADRS score of at least 20.
Age range: 18-65 years.
Exclusion criteria: Pregnancy, lactation, failure to use a safetable contraceptive method; concurrent major psychiatric disorders, such as anxiety disorder, dementia, somatoform disorders, agoraphobia, social phobia, any history of schizophrenia, psychosis or personality disorder; severe concurrent medical illness; alcohol or drug dependence; serious adverse reactions related to medicines; pprevious treatment with antidepressant for less than 3 week; major suicide risk
Interventions Fluoxetine: 120 participants.
Sertraline: 122 participants.
Fluoxetine dose range: 20-60 mg/day.
Sertraline dose range: 50-150 mg/day.
Outcomes Montgomery and Asberg Scale for Depression and Clinical Global Impression
Notes Response: decrease of at least 50% in the MADRS total score.
Funding: by industry
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear
HHS Vulnerability Disclosure