Study 329

Study 329 is a clinical trial sponsored by SmithKline Beecham, now GlaxoSmithKline, that examined the efficacy of paroxetine, an antidepressant, in treating major depressive disorder in adolescents. The study has been controversial due to allegations of data suppression and misrepresentation.

Background

Study 329 was conducted between 1994 and 1998, with the results published in 2001 in the Journal of the American Academy of Child and Adolescent Psychiatry. The study concluded that paroxetine was safe and effective for adolescents. However, this conclusion has been criticized and reevaluated in subsequent years.

Criticism and Controversy

The main criticism of Study 329 centers on allegations that the study's authors, who were paid by SmithKline Beecham, misrepresented the data to make paroxetine appear safer and more effective than it actually was. In 2002, the Attorney General of New York State filed a lawsuit against GlaxoSmithKline, alleging that the company had committed fraud by hiding negative information about paroxetine and promoting the drug for off-label use in adolescents.

Reanalysis of Study 329

In 2015, a reanalysis of the original data from Study 329 was published in the British Medical Journal. This reanalysis, conducted by the Restoring Invisible and Abandoned Trials (RIAT) initiative, concluded that paroxetine was neither safe nor effective for adolescents with major depressive disorder. This contradicted the original findings of Study 329.

Impact

The controversy surrounding Study 329 has had a significant impact on the pharmaceutical industry, leading to increased calls for transparency and data sharing. It has also raised questions about the role of pharmaceutical companies in sponsoring clinical trials and the potential for conflicts of interest.

See also

• Clinical trial
• Paroxetine
• Major depressive disorder
• GlaxoSmithKline
• Restoring Invisible and Abandoned Trials

References

Study 329 Resources
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