Child/Adolescent anxiety multimodal study: evaluating safety.

Journal Article (Clinical Trial, Phase III;Journal Article;Multicenter Study)

OBJECTIVE: To evaluate the frequency of adverse events (AEs) across 4 treatment conditions in the Child/Adolescent Anxiety Multimodal Study (CAMS), and to compare the frequency of AEs between children and adolescents. METHOD: Participants ages 7 to 17 years (mean = 10.7 years) meeting the DSM-IV criteria for 1 or more of the following disorders: separation anxiety disorder, generalized anxiety disorder, or social phobia were randomized (2:2:2:1) to cognitive-behavioral therapy (CBT, n = 139), sertraline (SRT, n = 133), a combination of both (COMB, n = 140), or pill placebo (PBO, n = 76). Data on AEs were collected via a standardized inquiry method plus a self-report Physical Symptom Checklist (PSC). RESULTS: There were no differences between the double-blinded conditions (SRT versus PBO) for total physical and psychiatric AEs or any individual physical or psychiatric AEs. The rates of total physical AEs were greater in the SRT-alone treatment condition when compared to CBT (p < .01) and COMB (p < .01). Moreover, those who received SRT alone reported higher rates of several physical AEs when compared to COMB and CBT. The rate of total psychiatric AEs was higher in children (≤12 years) across all arms (31.7% versus 23.1%, p < .05). Total PSC scores decreased over time, with no significant differences between treatment groups. CONCLUSION: The results support the tolerability/safety of selective serotonin reuptake inhibitor (SSRI) treatment for anxiety disorders even after adjusting for the number of reporting opportunities, leading to no differences in overall rates of AEs. Few differences occurred on specific items. Additional monitoring of psychiatric AEs is recommended in children (≤12 years). Clinical trial registration information-Child and Adolescent Anxiety Disorders (CAMS);; NCT00052078.

Full Text

Duke Authors

Cited Authors

  • 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; Birmaher, B

Published Date

  • March 2015

Published In

Volume / Issue

  • 54 / 3

Start / End Page

  • 180 - 190

PubMed ID

  • 25721183

Pubmed Central ID

  • PMC4362776

Electronic International Standard Serial Number (EISSN)

  • 1527-5418

Digital Object Identifier (DOI)

  • 10.1016/j.jaac.2014.12.015


  • eng

Conference Location

  • United States