Most antidepressants are ineffective, yet may be unsafe, for children and teenagers with depression, according to the most comprehensive study to date, published in The Lancet.
The findings show that out of 14 often recommended antidepressants, only fluoxetine was more effective at relieving symptoms than placebo, while venlafaxine was linked with an increased risk of engaging in suicidal thoughts and attempts compared with placebo and five other antidepressants.
However, the true effectiveness and risk of serious harms such as suicidal thoughts and attempts remains unclear because of the small number and poor design of clinical trials assessing these antidepressants, and the selective reporting of findings in published trials and clinical study reports, caution the authors.
"The balance of risks and benefits of antidepressants for the treatment of major depression does not seem to offer a clear advantage in children and teenagers, with probably only the exception of fluoxetine. We recommend that children and adolescents taking antidepressants should be monitored closely, regardless of the antidepressant chosen, particularly at the beginning of treatment," explains co-author Professor Peng Xie from The First Affiliated Hospital of Chongqing Medical University, Chongqing, China.
Major depression is thought to be common in children and adolescents, affecting around 3% of children aged 6 to 12 years and about 6% of teenagers aged 13 to 18 years. Even though psychological treatments are the first-line treatment for depression in many clinical guidelines, and in 2004 the US Food and Drug Administration (FDA) black box warning against the use of antidepressants in young people up to 24 years because of concern about increased risk of suicidality, the use of antidepressants, however, has slowly increased between 2005 and 2012. For example, the proportion of US children and teenagers (aged 0-19 years) taking antidepressants increased from 1.3% to 1.6%, and in the UK from 0.7% to 1.1%.
Based on the researchers’ systematic review and analysis of 34 trials involving 5260 participants, their findings showed that that the benefits outweighed the risks in terms of efficacy and tolerability only for fluoxetine. Nortriptyline was less efficacious than seven other antidepressants and placebo. Imipramine, venlafaxine, and duloxetine had the worst profile of tolerability, leading to significantly more discontinuations than placebo. Venlafaxine was linked with an increased risk of engaging in suicidal thoughts or attempts compared with placebo and five other antidepressants. The authors warn that due to the lack of reliable data, it was not possible to comprehensively assess the risk of suicidality for all drugs.
22 (65%) trials were funded by pharmaceutical companies. Ten (29%) trials were rated as high risk of bias, 20 (59%) as moderate, and four (12%) as low.
Overall quality of evidence for primary outcomes was rated as very low for most comparisons, which restricts the implications of the results for clinical practice.
Writing in a linked Comment, Dr Jon Jureidini at the University of Adelaide in Australia questions how many more suicidal events might have been revealed had individual patient-data been available. He points out, "[For example], in four trials of paroxetine versus placebo, only 13 (3%) of 413 events were reported in the paroxetine group; this seems implausible when individual patient-level data reanalysis of just one of those studies found ten events in only 93 patients given paroxetine (10.8%)."
He adds, "The effect of misreporting is that antidepressants, possibly including fluoxetine, are likely to be more dangerous and less effective treatments than has been previously recognized, so there is little reason to think that any antidepressant is better than nothing for young people.”
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