Abstract
That second observation is front and center in many of these investigations and motivates the papers in these pages that I would like to draw attention to, particularly Findling et al.'s interrogation of the safety and efficacy of ziprasidone in the treatment of schizophrenia in adolescents. The rationale for this study is perfectly clear; as the authors write, “among the atypical antipsychotics, quetiapine, risperidone, and olanzapine can have significant weight gain, endocrine, and metabolic side effects.” And although ziprasidone has a supporting literature regarding its use in adults, “there is limited information on its use in children and adolescents in rigorous randomized clinical trials.” Given the possibility of identifying a pharmacological intervention with an improved side effect profile in this vulnerable population, this is a medication that clearly deserves further study.
Unfortunately, as Findling et al. conclude, ziprasidone does not perform better than placebo in the study group of adolescents aged 13 to 17, though the medication was “generally well tolerated, with an overall neutral weight and metabolic profile.” This is a disappointing and also unexpected result given the evidence from adult trials. “The results of this study in the adolescent population were surprising,” the authors write. They detail some hopeful data points, and propose possible confounding factors such as “geographic variability in response,” but overall this is the story of a well-designed study with a negative outcome.
For this reason (among others) I am glad we are able to publish this paper. Not only does it contain many insights into study design and the management of at-risk populations—it is also an example of the global sharing of results, positive or negative, that can make one disappointing, even perplexing trial into a valuable contribution that spurs further inquiry. Why is ziprasidone ineffective in adolescents? How could this international study better identify and address confounding variables like geographic variability? I hope that considerations of these questions and more will soon appear in these pages.
Other astute investigations of alternative medication approaches to bipolar disorder and schizophrenia are also worthy of close reading, including Webb et al.'s study of aspirin in childhood onset schizophrenia and Frazier et al.'s paper on nutritional and safety outcomes of novel micronutrient treatments for pediatric bipolar disorder. I hope you find these and other articles as informative as I have.