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Proposal 669

Title of the Proposed Research

A multi-center, double-blind, placebo controlled study of paroxetine and imipramine in adolescents with unipolar major depression - efficacy and adverse outcomes

Lead Researcher

Jon Jureidini

Affiliation

University of Adelaide
Adelaide, AU

Funding Source

None

Potential Conflicts of Interest

Jureidini has been a critic of study 329 since it was first published and, as a result, has been contracted to provide expert advice for Baum Hedlund in a class action against GSK in relation to the prescribing of paroxetine to children and adolescents. He is a member of Healthy Scepticism. He reports no other conflicts.

Healy has been an expert witness on behalf of plaintiffs in legal cases involving paroxetine. He has also been a former consultant to and clinical triallist for SmithKline Beecham, and has consulted extensively with other pharmaceutical companies.

Raven is a member of Healthy Skepticism. She has participated in lobbying for the published article (Keller et al. 2001) to be retracted. She reports no other conflicts.

All real or potential conflicts will be published.

Data Sharing Agreement Date

24 January 2014

Lay Summary

Study 329 investigated the effectiveness of the antidepressant paroxetine (Paxil) in the treatment of adolescent depression. The published report, an article in the Journal of the American Academy of Child and Adolescent Psychiatry, concluded that Paxil was safe and effective. That publication was widely publicised and has contributed to increased rates of prescribing of paroxetine to children and adolescents. However, since shortly after the publication of the study, there have been concerns about the way in which the study was analysed and reported.

Our proposed research project is to re-analyse the data from the study (at the individual level) and report all findings objectively. This is part of an international movement to improve the integrity of medical trials. The findings will be submitted for publication in the BMJ. If we honestly and accurately re-analyse and republish the findings, we will enable doctors to make more informed prescribing decisions, thus benefiting patients.

Study Data Provided

Study 029060/329: A Multi-center, Double-blind, Placebo-Controlled Study of Paroxetine and Imipramine in Adolescents with Unipolar Major Depression

Statistical Analysis Plan

Publication Citation

Le Noury J, Nardo JM, Healy D, et al. Restoring Study 329: efficacy and harms of paroxetine and imipramine in treatment of major depression in adolescence. BMJ 2015;351:h4320.

Summary Results

Results summary or link will be posted when available.