A new study found that the antidepressant drug paroxetine (Paxil) is unsafe for teens, contrary to a previous study that concluded otherwise. In a newly published major medical journal, a group of researchers once again performed the old study, but yielded opposite results.
In 2013, a team of international scientists started the initiative called "restoring invisible and abandoned trials" (RIAT), wherein the funders and researchers of unpublished and misreported studies were urged to publish the findings of their investigations or correct inaccurate reports. In cases when the original authors failed to comply, independent study groups were pushed to redo and publish the correct findings of these clinical researches.
One of the researches that was subjected to this initiative is Study 329, which originally aimed to establish a comparison between the treatment effects of paroxetine with placebo and imipramine with placebo in adolescent patients diagnosed with major depression. In the said study, the researchers first screened the patients for 7-14 days. This was followed by an 8-week double-blind administration of paroxetine, imipramine and placebo in 275 qualified study subjects with major depression.
The findings of the initial research, published in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) in 2001, showed that patients who received paroxetine exhibited more significant improvement compared to those who received placebo in a number of depression measures used.
In the 2015 RIAT study, the researchers aimed to find out if a reanalysis of the complete dataset from a randomized controlled research will have clinical importance in the field of evidence-founded medicine. Generally, the same methods and procedures were employed in this current study.
The results of the reanalysis, published in The BMJ, showed that administering either paroxetine or imipramine did not demonstrate a notable difference in the effects of placebo for any of the efficacy measures. Aside from that, a significant rise in possible hazards such as suicidal ideation and other serious adverse effects was noted in the paroxetine group. For the imipramine cohort, cardiovascular problems were likely to increase in occurrence.
"This paper is alarming," said Brian Nosek, a psychology professor from the University of Virginia, who is not involved in both studies. However, the existence of such reanalysis is good because it signifies that the community is moved to check its work and to employ self-correction, which is what science is about.
