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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 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
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.
Outcomes Primary outcome: absolute change in the HDRS-21 total score.
Secondary outcomes: GCI Severity, CGI Improvement, MADRS, SASS, PGI, Quality of Sleep questionnaire
Notes Response: decrease of at least 50% in the HAM-D total score.
Remission: total score less than 10.
Funding: unclear
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear B - Unclear