PMID- 25721183 OWN - NLM STAT- MEDLINE DCOM- 20161017 LR - 20240322 IS - 1527-5418 (Electronic) IS - 0890-8567 (Print) IS - 0890-8567 (Linking) VI - 54 IP - 3 DP - 2015 Mar TI - Child/Adolescent anxiety multimodal study: evaluating safety. PG - 180-90 LID - S0890-8567(14)00894-6 [pii] LID - 10.1016/j.jaac.2014.12.015 [doi] AB - 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 (