Methods | Six-week randomised, double-blind multicentre study. | |
Participants | Outpatients fulfilling DSM-IV criteria for unipolar major depressive disorder, with a score of at least 14 on the HDRS-21. Age range: 18-62 years old. Exclusion criteria: diagnosis of amood disorder to a secondary general medical condition, bipolar disorder, substance abuse, history of prior treatment with sertraline or fluoxetine. For patients with a history of substance abuse a period of 30 days of sobriety was required prior to study entry |
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Interventions | Fluoxetine: 18 participants. Sertraline (50 mg): 17 participants. Sertraline (100 mg): 17 participants. Fluoxetine dose: 20 mg/day. Lorazepam (0.5 mg) was allowed. |
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Outcomes | Primary outcome: a HDRS score of maximum 7 or a CGI score of maximum 2 at endpoint (remission) | |
Notes | Funding: by industry | |
Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |