title: Child/Adolescent anxiety multimodal study: evaluating safety.
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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Columbia University Medical Center (CUMC)/New York State Psychiatric Institute, New York. Electronic address: rynnm@nyspi.columbia.edu.
authors.forename: Moira A
authors.initials: MA
authors.lastname: Rynn
authors.affiliation: Weill Cornell Medical College and New York Presbyterian Hospital, New York.
authors.forename: John T
authors.initials: JT
authors.lastname: Walkup
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: Scott N
authors.initials: SN
authors.lastname: Compton
authors.affiliation: Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh.
authors.forename: Dara J
authors.initials: DJ
authors.lastname: Sakolsky
authors.affiliation: Division of Services and Intervention Research at the National Institute of Mental Health (NIMH), Bethesda, MD.
authors.forename: Joel T
authors.initials: JT
authors.lastname: Sherrill
authors.affiliation: University of Illinois at Urbana-Champaign.
authors.forename: Sa
authors.initials: S
authors.lastname: Shen
authors.affiliation: Temple University, Philadelphia.
authors.forename: Philip C
authors.initials: PC
authors.lastname: Kendall
authors.affiliation: University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior.
authors.forename: James
authors.initials: J
authors.lastname: McCracken
authors.affiliation: Columbia University Medical Center (CUMC)/New York State Psychiatric Institute, New York.
authors.forename: Anne Marie
authors.initials: AM
authors.lastname: Albano
authors.affiliation: University of California, Los Angeles (UCLA) Semel Institute for Neuroscience and Human Behavior.
authors.forename: John
authors.initials: J
authors.lastname: Piacentini
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD.
authors.forename: Mark A
authors.initials: MA
authors.lastname: Riddle
authors.affiliation: Johns Hopkins University School of Medicine, Baltimore, MD.
authors.forename: Courtney
authors.initials: C
authors.lastname: Keeton
authors.affiliation: Baystate Medical Center, Springfield, MA.
authors.forename: Bruce
authors.initials: B
authors.lastname: Waslick
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: Allan
authors.initials: A
authors.lastname: Chrisman
authors.affiliation: Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh.
authors.forename: Satish
authors.initials: S
authors.lastname: Iyengar
authors.affiliation: Duke University Medical Center, Durham, NC.
authors.forename: John S
authors.initials: JS
authors.lastname: March
authors.affiliation: Western Psychiatric Institute and Clinic-University of Pittsburgh Medical Center, Pittsburgh.
authors.forename: Boris
authors.initials: B
authors.lastname: Birmaher
mesh_terms: D000293:Adolescent; D001010:Anxiety, Separation / Q000628:therapy*; D002648:Child; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D016015:Logistic Models; D008297:Male; D010698:Phobic Disorders / Q000628:therapy*; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline
keywords: adverse events; anxiety; selective serotonin reuptake inhibitors