Data from Study 329, that Claimed to show Paroxetine is Safe and Effective for Adolescents, Actually Showed the Opposite — (Various)

SSRI Ed note: 2001 Study 329 findings contradicted based on original data

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Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence – BMJ

by Joanna Le Noury, John M Nardo, David Healy, Jon Jureidini, Melissa Raven, Catalin Tufanaru, and Elia Abi-Jaoude, published Sept. 16, 2015

Below is a selection of media stories on the BMJ Article Restoring Study 329, with the link, title and lead-off sentence of each:

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1. Antidepressant Paxil Is Unsafe for Teenagers, New Analysis Says, By Benedict Carey

The New York Times

Fourteen years ago, a leading drug maker published a study showing that the antidepressant Paxil was safe and effective for teenagers. On Wednesday, a major medical journal posted a new analysis of the same data concluding that the opposite is true…


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2. Re-analysis of controversial Paxil study shows drug “ineffective and unsafe” for teens

Retraction Watch

The antidepressant Paxil isn’t safe or effective for teens after all, says a re-analysis of a 2001 study published today in The BMJ.


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3.Antidepressant paroxetine tips young people into suicide: study, by John Ross

The Australian

An Australian-led study of a popular antidepressant has shown that it can tip young people­ into suicide.  In a rare re-analysis of a contro­versial clinical trial, the researchers­ found that the drug paroxetine — touted in 2001 as safe and effective for teenagers — was neither.


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4. Seroxat study under-reported harmful effects on young people, say scientists | Science, by Sarah Boseley

The Guardian

Experts who re-analysed data say study is still referred to in medical literature and needs to be retracted.  An influential study which claimed that an antidepressant drug was safe for children and adolescents failed to report the true numbers of young people who thought of killing themselves while on it, re-analysis of the trial has found.  Study 329, into the effects of GlaxoSmithKline’s drug paroxetine on under-18s, was published in 2001 and later found to be flawed.