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Matches in DBpedia 2016-04 for { <http://dbpedia.org/resource/Study_329> ?p ?o }

• Study_329 abstract "Study 329 was a clinical trial conducted in North America from 1994 to 1998 to study the efficacy of paroxetine, an SSRI anti-depressant, in treating depressed teenagers. Marketed as Paxil and Seroxat (among other names), paroxetine had been released in 1991 by the British pharmaceutical company SmithKline Beecham, known since 2000 as GlaxoSmithKline (GSK). The drug made $11.6 billion between 1997 and 2006.Led by Martin Keller, then professor of psychiatry at Brown University, study 329 became controversial when it was discovered that the article which reported the trial results – published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry (JAACAP) – had downplayed the trial's negative findings and had been ghostwritten by a PR firm hired by SmithKline Beecham. The controversy led to several lawsuits and strengthened calls for drug companies to disclose all their clinical research data. New Scientist wrote in 2015: \"You may never have heard of it, but Study 329 changed medicine.\"The study, which compared paroxetine with imipramine, a tricyclic antidepressant marketed as Tofranil, failed to show efficacy for paroxetine in adolescent depression, something SmithKline Beecham acknowledged internally in 1998. In addition there were more examples of suicidal thinking and behaviour in the group taking paroxetine. Although the article included these negative results, it did not account for them in its conclusion. On the contrary, it concluded that paroxetine is \"generally well tolerated and effective for major depression in adolescents.\" The company relied on the article to promote paroxetine for off-label use in teenagers.In 2003 Britain's Medicines and Healthcare Products Regulatory Agency (MHRA) analysed study 329 and other GSK studies of paroxetine. It concluded that there was no evidence of paroxetine's efficacy and a clear increase in suicidal behaviour in teenagers using it. The following month the MHRA and US Food and Drug Administration (FDA) advised doctors not to prescribe paroxetine to the under-18s. The MRHA launched a criminal inquiry into GSK's conduct, but announced in 2008 that there would be no charges. In 2004 New York State Attorney Eliot Spitzer sued GSK for having withheld the data. In 2012 the US Justice Department fined the company $3 billion, including a sum for withholding data on paroxetine, unlawfully promoting it for the under-18s, and preparing a misleading article on study 329.The JAACAP article on study 329 was never retracted. The journal's editors say the negative findings are included in a table, and that therefore there are no grounds to withdraw the article. In September 2015 the BMJ published a re-analysis of study 329's data. This concluded that neither paroxetine nor imipramine had differed in efficacy in treating depression from placebo (an inert pill), that the paroxetine group had experienced more suicidal ideation and behaviour, and that the imipramine group had experienced more cardiovascular problems.".
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• Study_329 wikiPageWikiLink Major_depressive_disorder.
• Study_329 wikiPageWikiLink Martin_Keller_(psychiatrist).
• Study_329 wikiPageWikiLink Medicaid.

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