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Study finds most antidepressants not very effective in youth.

Most antidepressants prescribed to children and adolescents with acute major depression might not be nearly as effective as they are believed to be, according to a review including more than 5,000 participants.

The review looked at a total of 34 double-blind, randomized, controlled trials investigating at least 1 of 14 major drugs typically prescribed as antidepressants for pediatric patients. The researchers looked at amitriptyline, citalopram, clomipramine, desipramine, duloxetine, escitalopram, fluoxetine, imipramine, mirtazapine, nefazodone, nortriptyline, paroxetine, sertraline, and venlafaxine (Lancet. 2016 Jun 8. doi: 10.1016/S0140-6736[16]30385-3).

"Unfortunately, due to the absence of reliable data on suicidality for many antidepressants, it was not possible to comprehensively assess the risk of suicidality for all drugs," wrote Dr. Andrea Cipriani, Xinyu Zhou, Ph.D., and their colleagues.

All trials were published before May 31, 2015, and were found in the PubMed, Cochrane Library, Web of Science, Embase, CINAHL, PsycINFO, and LiLACS databases, as well as regulatory agencies' websites, and international registers for published and unpublished trials. Trials either compared one or more drugs against one another, or one or more drugs against a placebo.

Fluoxetine was the only drug found to be significantly more effective than placebo (standardized mean difference -0.51, 95% credible interval [CrI] -0.99 to -0.03), and it also was found to be significantly more effective than nortriptyline. In addition, fluoxetine proved better tolerated than imipramine (odds ratio, 0.23; CrI, 0.04 to 0.78) and duloxetine (OR, 0.31; 95% CrI 0.13 to 0.95).

"However, the clinical interpretation of these findings is limited not only by the uncertainty around these estimates, but also by the potential bias due to selective reporting and the small number of trials," according to Dr. Cipriani of the University of Oxford (England) and Dr. Zhou of the First Affiliated Hospital of Chongqing (China) Medical University.

Regardless of which treatment clinicians choose, children and adolescents prescribed antidepressants should be monitored closely. Clinical guidelines for young people with major depression recommend psychotherapy, particularly cognitive-behavioral therapy or interpersonal therapy as first-line interventions, and "fluoxetine should be considered only for those patients with moderate to severe depression who do not have access to psychotherapy or have not responded to nonpharmacological interventions," the researchers said.

The study has "disturbing implications for clinical practice" in that it concludes that the risk-benefit profile of antidepressants in the acute treatment of major depression in children and adolescents "does not seem to offer a clear advantage" for these young patients, Dr. Jon Jureidini, Ph.D., wrote in an accompanying editorial (Lancet. 2016 jun 8. doi: 10.1016/S0140-6736[16]30385-2).

For clinicians, the implications are that every decision about whether and what to prescribe requires a calculation on the part of the clinician that is both complex and intuitive, Dr. Jureidi said.

"With research evidence as an important part of that calculation, we now know that we need to make a conscious correction for favorable misrepresentation of outcomes in published and unpublished study reports," said Dr. Jureidini, who is a research leader for the Robinson Research Institute at the University of Adelaide in North Adelaide, Australia.

"Only if the discounted benefit outweighs the boosted harm should the treatment be prescribed. For antidepressants in adolescents, this equation will rarely favor prescribing; in younger children, almost never," he concluded.

The study was funded by the National Basic Research Program of China. The authors did not report any relevant financial disclosures.


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Author:Chitnis, Deepak
Publication:Pediatric News
Date:Jul 1, 2016
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