Study 329 continuation phase: safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression
Study 329, a clinical trial conducted in North America from 1994 to 1998, had one objective only: to …
This article is part of the RIAT initiative (Restoring Invisible and Abandoned Trials) and aims to restore the misreported trial that is known as Study 329, funded by SmithKline Beecham (subsequently GlaxoSmithKline). In contrary to the conclusions stated in the original article, these authors found neither clinically relevant nor statistically significant differences in the primary and secondary outcomes between placebo and the drugs under investigation (paroxetine and imipramine). However, clinically relevant increases in harms were found!
Title: Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence
Authors: Le Noury J, Nardo JM, Healy D, Jureidin J, Raven M, Tufanaru C, Abi-Jaoude E
doi: 10.1136/bmj.h4320 (2015)
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