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Adolescent antidepressant study was "flawed"

Thursday September 17th, 2015

A commonly used antidepressant was wrongly reported as being safe and effective for adolescents at the beginning of the century, researchers reported today.

A fresh analysis of a study which claimed benefits for paroxetene has found that its conclusions were wrong.

The research was published by a drug company and has now been re-analysed by academics taking advantage of a scheme which has made available previously unreleased data.

In 2002 US authorities criticised the research, known as study 329 - but still lacked full details, according to the academics.

The new analysis has found that 11 of the adolescents prescribed the drug engaged in suicidal or self-harming behaviour. This compared with just one of those prescribed placebo.

Reporting in The BMJ, the researchers say the new analysis shows the drug was no more effective than placebo.

Professor Jon Jureidini, from the University of Adelaide's Critical and Ethical Mental Health Research Group, said: "This is highly concerning because prescribing this drug may have put young patients at unnecessary risk from a treatment that was supposed to help them.

He added: "Study 329 was one of the trials identified as in need of restoration, and because the original funder was not interested in revisiting the trial, our research group took on the task.

"Our reanalysis of Study 329 came to very different conclusions to those in the original paper," he says. "We also learnt a lot about incorrect reporting and the considerable fall out that can be associated with distorted data."

BMJ editor Dr Fiona Godlee said the new analysis "set the record straight," warning that "drug regulation is failing us."

Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence BMJ 17 September 2015 [abstract]

Tags: Australia | Infancy to Adolescence | Mental Health | North America

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