Methods | Eight-week double-blind, randomised multicentre study. | |
Participants | In- and outpatients meeting DSM-III-R diagnostic criteria for major depression, with a minimum baseline score of 22 on the 21-item HDRS, recruited from 33 clinical sites. Age range: 18-65 years. Exclusion criteria: history of unresponsiveness to antidepressant treament, association with endocrine disorders, substance abuse, drug hypersensitivity, chronic respiratory insufficiency, or gastro-intestinal, hepatic or renal disease, ECT within 6 months of baseline, high risk of suicide, pregnancy or absence of adequate contraception measures |
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Interventions | Fluoxetine: 127 participants. Reboxetine: 126 participants. Placebo: 128. Fluoxetine dose range: 20-40 mg/day. Reboxetine dose range: 8-10 mg/day. Chloral hydrate (0.5-1 g) was allowed as hypnotic. |
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Outcomes | Primary outcome: absolute change in the HDRS-21 total score. Secondary outcomes: GCI Severity, CGI Improvement, MADRS, SASS, PGI, Quality of Sleep questionnaire |
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Notes | Response: decrease of at least 50% in the HAM-D total score. Remission: total score less than 10. Funding: unclear |
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Risk of bias | ||
Item | Authors’ judgement | Description |
Allocation concealment? | Unclear | B - Unclear |