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Review: reboxetine is ineffective and potentially harmful for acute treatment of major depression

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How clinically effective and safe is reboxetine for acute treatment of major depression and what is the effect of publication bias on reported effect measures?


Remission, response, adverse events and withdrawals due to adverse events compared with selective serotonin reuptake inhibitors (SSRIs) or placebo.



Systematic review with meta-analysis.

Data sources

Medline, Embase, PsycINFO, BIOSIS, Cochrane Library, clinical trial registries, trial results databases and regulatory authority websites were searched up until February 2009. Unpublished data were obtained from the manufacturer (Pfizer, Berlin, Germany), and reference lists of primary and secondary publications were hand searched for additional references.

Study selection and analysis

Double blinded randomised controlled trials comparing reboxetine versus placebo or SSRIs for the acute treatment of adults with a primary diagnosis of DSM-IV major depressive disorder were included. Trials had to last at least 6 weeks for inclusion. Selected trials had at least one prespecified outcome and were published in English, French or German (or any other language providing that relevance could be ascertained from the English title or abstract). Response and remission were defined according to the primary studies. All of the studies used the Hamilton Depression Rating Scale and defined ‘response’ as a reduction in score of ≥50% from baseline …

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  • Sources of funding Institute for Quality and Efficiency in Health Care, Germany. Project commissioned by the German Federal Joint Committee.


  • Competing interests MAK has received grants or research support from CIHR, Sick Kids Foundation, Centre for Addiction and Mental Health Foundation, Canadian Psychiatric Research Foundation, Canadian Foundation for Innovation, GlaxoSmithKline, Wyeth Pharmaceuticals, Lundbeck Canada, Eli Lilly, Organon, Astra Zeneca, Janssen-Ortho, Solve, Genuine Health, Shire, Bristol-Myers Squib, Boehringer Ingelheim, VNS, Genuine Health, Pfizer, Servier, Sanofi Aventis and Brain Cells (BCI). He has also received speaker honoraria from GlaxoSmithKline, Wyeth Pharmaceuticals, Lundbeck, Eli Lilly, Boehringer Ingelheim, Organon, Astra Zeneca, Janssen-Ortho, Solve, Bristol-Myers Squib, Shire Canada, Canada, Pfizer and Biovail.