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Child/Adolescent Anxiety Multimodal Study: Evaluating Safety
Rynn MA, Walkup JT, Compton SN, Sakolsky DJ, Sherrill JT, Shen S, Kendall PC, McCracken J, Albano AM, Piacentini J, Riddle MA, Keeton C, Waslick B, Chrisman A, Iyengar S, March JS and Birmaher B.
Journal of the American Academy of Child and Adolescent Psychiatry, 54:180-190, 2015

Anxiety disorders are among the most common childhood psychiatric disorders, with lifetime prevalence rates ranging from 15% to 20%.  Despite evidence for the efficacy of selective serotonin reuptake inhibitors in the treatment of pediatric anxiety disorders, these compounds have also been associated with treatment-emergent adverse events.

Dr. Boris Birmaher and colleagues at the University of Pittsburgh collaborated with Dr. Moira Rynn and others to evaluate the frequency of adverse events across four treatment conditions in the Child/Adolescent Anxiety Multimodal Study.  The researchers recruited children and adolescents aged 7 to 17 years old that met the DSM-IV criteria for one or more of the following disorders:  separation anxiety disorder, generalized anxiety disorder, or social phobia.  Participants were randomized to cognitive-behavioral therapy (CBT), sertraline, a combination of both, or pill placebo.  The investigators also compared the frequency of adverse events between children and adolescents.  

No differences were found between the double-blinded conditions (sertraline vs. placebo) for total physical and psychiatric adverse events or any individual physical or psychiatric adverse events. The rates of total physical adverse events were greater in the sertraline-alone treatment condition when compared to CBT and a combination of sertraline and CBT. Moreover, those who received only sertraline reported higher rates of several physical adverse events when compared to a combination of sertraline and CBT. The rate of total psychiatric adverse events was higher in children ages 12 years old and younger across all study arms.  

The results of this project support the tolerability/safety of selective serotonin reuptake inhibitor treatment for anxiety disorders even after adjusting for the number of reporting opportunities.  Findings also indicate that additional monitoring of psychiatric adverse events is needed in children ages 12 years old and younger. 

Contributors:
Dara J. Sakolsky, MD, PhD and Boris Birmaher, MD (Department of Psychiatry, University of Pittsburgh)

Satish Iyengar, PhD (Department of Statistics, University of Pittsburgh)

Moira A. Rynn, MD and Anne Marie Albano, PhD (Department of Psychiatry, Columbia University Medical Center)

John T. Walkup, MD (Department of Psychiatry, Weill Cornell Medical College)

Scott N. Compton, PhD, Allan Chrisman, MD and John S. March, MD, MPH (Duke University Medical Center)

Joel T. Sherrill, PhD (Division of Services and Intervention Research, National Institute of Mental Health)

Sa Shen, PhD (Center on Health, Aging, and Disability, University of Illinois at Urbana–Champaign)

Philip C. Kendall, PhD (Department of Psychology, Temple University) 

James McCracken, MD and John Piacentini, PhD (Semel Institute for Neuroscience and Human Behavior, University of California, Los Angeles)

Mark A. Riddle, MD and Courtney Keeton, PhD (Department of Psychiatry and Behavioral Sciences, Johns Hopkins University School of Medicine)

Bruce Waslick, MD (Baystate Medical Center) 

This article appeared in the Journal of the American Academy of Child and Adolescent Psychiatry.  Click here to view the abstract.