A recent re-examination of a 2001 study found that claims of the antidepressant paroxetine being safe for teenagers were misleading. (Source: Wikimedia Commons)
A re-examination of a 2001 study testing the efficacy and safety of an antidepressant for adolescents has found that the drug was misrepresented as safe in its report. The study in question, Study 329 was a double-blind randomized controlled trial conducted to evaluate the efficacy and safety of paroxetine compared with placebo for adolescents diagnosed with major depression (1). It was published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry and has been influential in supporting the use of antidepressants in teens (2).
Researchers at the University of Adelaide, led by Professor Jon Jureidini of the Critical and Ethical Mental Health research group, found that the data from Study 329 not only showed no advantages of taking paroxetine, but adverse effects. Professor Jureidini says that taking paroxetine was linked to serious adverse reactions, with 11 of those taking paroxetine engaging in self-harm compared to only one in the placebo group (3).
The re-examination of Study 329 was part of an initiative called restoring invisible and abandoned trials (RIAT), started in 2013 to call on funders of unpublished or misreported trials to publish undisclosed outcomes or correct misreported publications. Study 329 was one of the studies marked as in need of restoration. The original funder, SmithKline Beecham, now GlaxoSmithKline, did not intend to correct the study, so the group led by Professor Jureidini decided to revisit the trial (1, 2).
Professor Jureidini concludes that the reanalysis of Study 329 led to very different conclusions from the original study. He suggests the necessity of making trial data available to increase the rigor of evidence-based research (2).
The re-examination, titled “Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence,” has been published in the medical journal BMJ.
References:
- Keller, M. B., Ryan, N. D., Strober, M., Klein, R. G., Kutcher, S. P., Birmaher, B., … & McCafferty, J. P. (2001). Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. Journal of the American Academy of Child & Adolescent Psychiatry, 40(7), 762-772. doi:10.1097/00004583-200107000-00010
- Le Noury, J., Nardo, J. M., Healy, D., Jureidini, J., Raven, M., Tufanaru, C., Abi-Jaoude, E. (2015). Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ, 351. doi: http://dx.doi.org/10.1136/bmj.h4320
- University of Adelaide. (2015, September 16). Antidepressant was misrepresented as safe for adolescents. ScienceDaily. Retrieved September 20, 2015 from www.sciencedaily.com/releases/2015/09/150916185107.htm