Study 329 continuation phase: safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression

Last modified: May 29, 2017

Study 329, a clinical trial conducted in North America from 1994 to 1998, had one objective only: to compare the efficacy and safety of paroxetine and imipramine with placebo in the treatment of teenagers with major depression. However, Study 329 became controversial when it was discovered that researchers involved had not only downplayed the trial’s negative findings, but that the article itself had been ghostwritten by a PR firm.

Although much has been written about the first 8 weeks of study 329, this article presents a re-analysis of the unpublished continuation phase. Once again the results diverge from the original report. It shows that the continuation phase does not offer support for longer-term efficacy of either paroxetine or imipramine. The authors strongly suggest that the prescription of these drugs in practice should be re-evaluated.

Read more about study 329, the reanalysis of the original results and the BMJ feature about the resistance to action on the initial discovery of misreporting of this trial.
The reanalysis of Study 329 is part of the RIAT initiative.

Publication

Title: Study 329 continuation phase: safety and efficacy of paroxetine and imipramine in extended treatment of adolescent major depression
Authors: Le Noury J, Nardo JM, Healy D, Jureidini J, Raven M, Tufanaru C, Abi-Jaoude E.
doi: 10.32233/JRS-160728 (2016)

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