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Clinical Trial
. 2015 Mar;54(3):180-90.
doi: 10.1016/j.jaac.2014.12.015. Epub 2014 Dec 31.

Child/Adolescent anxiety multimodal study: evaluating safety

Moira A Rynn  1 , John T Walkup  2 , Scott N Compton  3 , Dara J Sakolsky  4 , Joel T Sherrill  5 , Sa Shen  6 , Philip C Kendall  7 , James McCracken  8 , Anne Marie Albano  9 , John Piacentini  8 , Mark A Riddle  10 , Courtney Keeton  10 , Bruce Waslick  11 , Allan Chrisman  3 , Satish Iyengar  4 , John S March  3 , Boris Birmaher  4
Affiliations
Clinical Trial

Child/Adolescent anxiety multimodal study: evaluating safety

Moira A Rynn et al. J Am Acad Child Adolesc Psychiatry. 2015 Mar.

Abstract

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); http://clinicaltrials.gov; NCT00052078.

Keywords: adverse events; anxiety; selective serotonin reuptake inhibitors.

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Figure 1
Figure 1
Change of average Physical Symptom Checklist (PSC) scores over time. Note: CBT = cognitive-behavioral therapy.
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