Researchers question Iranian fluoxetine trial involving 40 children — Nature
Researchers have questioned the results of a clinical trial of fluoxetine in Iran, published in 2006 and involving 40 children. It may have significantly influenced the evidence base supporting the use of fluoxetine, known by the brand name Prozac, to treat depression in children and adolescents. As Nature reports, the authors of a new analysis consider the data from this study insufficiently reliable for use in the evidence base.
Fluoxetine is recommended in a number of clinical guidelines for treating depression among children and adolescents. At the same time, the authors of the new study are not calling on doctors to stop prescribing the drug. They propose that guideline-development committees revise their recommendations in light of the clarified data.
Discrepancies between meta-analyses
A 2016 meta-analysis in The Lancet and a 2020 meta-analysis in The Lancet Psychiatry concluded that fluoxetine is more effective than placebo for children and adolescents with depression. In contrast, a 2021 review in the Cochrane Database of Systematic Reviews found only a small and clinically unimportant advantage of the drug over placebo and suggested that it is probably no better than other antidepressants.
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Florian Nöde, Martin Plöderl and their colleagues reanalysed the data from the 2016 and 2020 meta-analyses without the Iranian trial. According to their conclusions, the significant advantage of fluoxetine disappeared after these data were excluded. The 2021 Cochrane review did not include this study because its authors excluded comparisons with the class of antidepressants to which nortriptyline belongs.
Questions about the trial data
In the Iranian study, fluoxetine demonstrated an exceptionally large advantage over nortriptyline that no other trial of the drug for treating depression in children has shown. Researchers also noted that the reported data indicate similar changes in depression scores among all participants in each of the two groups, which is atypical for clinical trials. The publication also did not describe the ethical approval procedure.
Publisher MedKnow said it had asked the journal's editorial team to review the matter. Andrea Cipriani, a co-author of the 2016 and 2020 meta-analyses, agreed that the trial data are problematic. According to him, the authors of the previous meta-analyses had noted weak methodology, a risk of bias and very low certainty in the conclusions regarding fluoxetine.
