EMBARGOED FOR RELEASE: 11 A.M. (ET), WEDNESDAY, JUNE 13, 2018
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Bottom Line: Increases in body fat and decreases in insulin sensitivity were observed in youths with disruptive behavior disorders who were treated for the first time with antipsychotic medications during a 12-week randomized clinical trial.
Why The Research Is Interesting: Treatment with antipsychotic medications has been associated with risks of weight gain, type 2 diabetes and related conditions. Antipsychotic medications are commonly prescribed off-label for children with attention-deficit/hyperactivity disorder (ADHD) and disruptive behavior disorders.
Who and When: 144 youths (ages 6 to 18) with distruptive behavior disorders (almost 56 percent had a primary diagnosis of ADHD with irritability and aggression that was insufficiently responsive to prior therapy) from the St. Louis metropolitan area; participants were enrolled in the trial from 2006-2010
What (Study Interventions and Outcomes): 12 weeks of treatment with oral aripiprazole (49 younths), olanzapine (46 youths) or risperidone (49 youths) (interventions); percentage total body fat and insulin sensitivity in muscle (primary outcomes), plus abdominal fat and other insulin sensitivity measures (secondary outcomes)
How (Study Design): This was a randomized clinical trial (RCT). RCTs allow the strongest inferences to be made about the true effect of an intervention. However, not all RCT results can be replicated in real-world settings because patient characteristics or other variables may differ from those studied in the RCT.
Authors: John W. Newcomer, M.D., of Florida Atlantic University, Boca Raton, Florida, Ginger E. Nicol, M.D., of Washington University in St. Louis, and coauthors
Study Limitations: The 12-week trial was shorter than the long-term treatment many patients receive; there was no placebo group for ethical and feasibility reasons
Related Material: The editorial, “The Urgent Need for Optimal Monitoring of Metabolic Adverse Effects in Children and Youngsters Who Take On-Label or Off-Label Antipsychotic Medication,” by Marc De Hert, M.D., Ph.D., and Johan Detraux, M.Psy., of Katholieke Universiteit Leuven, Kortenberg, Belgium, also is available on the For The Media website.
To Learn More: The full study is available on the For The Media website.
Editor’s Note: The article includes conflict of interest and funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.
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