Methods | Eight-week randomised, double-blind, multicentre study. | |
Participants | Outpatients fulfilling DSM-IV criteria for non-psychotic major depressive disorder, with a score of at least 15 on the HDRS-17 and at least 4 on the CGI-Severity of Illness. Age range: 18-65 years old. Exclusion criteria: any primary DSM-IV Axis I diagnosis other than major depressive disorderr or any anxiety disorder as a primary diagnosis within the past year with the exception of specific phobias, history of substance abuse or dependence within the past year or a positive urine drug screen at study entry, failure of 2 or more adequate courses of antidepressant therapy during the present episode |
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Interventions | Fluoxetine: 33 participants. Duloxetine: 70 participants. Placebo: 70 participants. Fluoxetine dose: 20 mg/day. Duloxetine dose: 40-120 mg/day. |
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Outcomes | Primary outcomes: Hamilton Rating Scale for Depression (HDRS-17). Secondary outcomes: Montgomery and Asberg Scale for Depression (MADRS), CGI, PGI, Hamilton Rating Scale for Anxiety |
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Notes | Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |