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Paroxetine Deemed Ineffective Unsafe for Depressed Teens

Reanalysis of primary data from Study 329 contradicts findings of original research

THURSDAY, Sept. 17, 2015 (HealthDay News) -- In the first trial reanalyzed under the Restoring Invisible and Abandoned Trials (RIAT) initiative, the results contradict the original research findings that reported paroxetine to be a safe and effective treatment for major depression in adolescents. The new research was published online Sept. 16 in The BMJ.

Joanna Le Noury, PhD, of Bangor University in the United Kingdom, and colleagues reanalyzed the primary data from SmithKline Beecham's Study 329, published by Keller and colleagues in 2001, which had a primary objective of comparing the efficacy and safety of paroxetine and imipramine with that of placebo in the treatment of adolescents with unipolar major depression. The reanalysis was done to determine whether access to, and reanalysis of, a full dataset from a randomized controlled trial would have a clinically relevant effect on evidence-based medicine.

The researchers found that the efficacy of paroxetine and imipramine was not statistically or clinically significantly different from placebo for any of the prespecified primary or secondary efficacy outcomes. Clinically significant increases in harms, including suicidal ideation and behavior and other serious adverse effects, occurred in the paroxetine group. Cardiovascular problems were reported in the imipramine group.

"It is often said that science self corrects," writes the associate editor of The BMJ in an accompanying feature article. "But for those who have been calling for a retraction of the Keller paper for many years, the system has failed."

One study author has served as an expert witness for plaintiffs in cases involve paroxetine and similar antidepressants. Another author has been paid to provide expert analysis in a class-action lawsuit over Study 329.

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