“The original study says paroxetine is safe and effective for the treatment of depressed adolescents”, said co-author Dr. John Nardo, a psychiatrist with the Emory University Psychoanalytic Institute in Atlanta. “And I don’t know of any example where two studies in the literature with the same data ever reached opposite conclusions”. This move is part of the Restoring Invisible and Abandoned Trials project which seeks to make clinical trials more transparent and available to all.

Yet, through all of this controversy – and despite numerous calls that original study be retracted – the authors of Study 329, as well as the journal that published it, stood by their findings.

The original trial, funded by the drug’s marketer, has been controversial since it was published 14 years ago. The medication is now marketed in the United States by the drug company Apotex, GSK officials said.

Prosecutors claimed the drugmaker had fraudulently claimed the drug’s efficacy and promoted its use in adolescents, even though trials showed its ineffectiveness in that age group.

The FDA requires all antidepressants come with a warning of the increased risk of suicide for children and adolescents.

She called for legislation to ensure results of all clinical trials, including individual patient data, were made available for “legitimate third-party scrutiny”, with criminal convictions for non-compliance, adding that clinical trials should not be directly paid for or managed by industry.

The first paper from the trial, published in 2001, involved 275 teens with depression. The participants were randomized in the trial to receive eight weeks of treatment with paroxetine, imipramine, or a placebo.

A review of the popular antidepressant drug paroxetine has revealed that the drug is no more effective than a placebo. Many parents of teens on the drug have also launched lawsuits against GlaxoSmithKline (GSK), the maker of Paxil, alleging that their children had serious reactions to the drug. One of the biggest discrepancies (besides the drug’s overall effectiveness) was the frequency of suicidal thinking and events, which appears to have been underreported by the original researchers, according to the authors of the new BMJ analysis. Some were categorized as “emotional lability” – the tendency to laugh or cry unexpectedly – and this masked differences in suicidal behavior between Paxil and placebo, the reanalysis found.

A common antidepressant has been linked to suicide in adolescents in a new study.

“To describe our trial as “misreported” is pejorative and wrong, both from consideration of best research practices at the time, and in terms of a retrospective from the standpoint of current best practices”, they wrote.

That study – featured prominently by the journal BMJ – is a clear break from scientific custom and reflects a new era in scientific publishing, some experts said, opening the way for journals to post multiple interpretations of the same experiment. By contrast, Jureidini said a review found the number was at least 12, which is high. Together, these problems masked issues with the drug, making it look more safe than it actually was.