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 |
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Interventions | Fluoxetine: 120 participants. Sertraline: 122 participants. Fluoxetine dose range: 20-60 mg/day. Sertraline dose range: 50-150 mg/day. |
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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 |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |