Benefits and harms in clinical trials of duloxetine for treatment of major depressive disorder: comparison of clinical study reports, trial registries, and publications.

ABSTRACT:

Objective

To determine, using research on duloxetine for major depressive disorder as an example, if there are inconsistencies between protocols, clinical study reports, and main publicly available sources (journal articles and trial registries), and within clinical study reports themselves, with respect to benefits and major harms.

Design

Data on primary efficacy analysis and major harms extracted from each data source and compared.

Setting

Nine randomised placebo controlled trials of duloxetine (total 2878 patients) submitted to the European Medicines Agency (EMA) for marketing approval for major depressive disorder.

Data sources

Clinical study reports, including protocols as appendices (total 13,729 pages), were obtained from the EMA in May 2011. Journal art

SUBMITTER: Maund E 

PROVIDER: S-EPMC4045316 | biostudies-literature | 2014 Jun

REPOSITORIES: biostudies-literature