title: Clinical evaluation of the efficacy and safety of tandospirone versus sertraline monotherapy for social anxiety disorder: a randomized open-label trial.
abstract: OBJECTIVE
  Although selective serotonin reuptake inhibitors are now established as first-line pharmacotherapy for social anxiety disorder (SAD), other agents with different mechanisms have shown promise in treating SAD. The aim of this study was to examine the efficacy and safety of tandospirone in treating adolescents with SAD.
  
  
  METHODS
  Adolescent patients meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for SAD were randomly assigned (1:1) to open-label treatment with either tandospirone or sertraline for 8 weeks. The primary outcome measures were changes from baseline in the Hamilton Anxiety (HAM-A) scale and response using the Clinical Global Impression of Improvement (CGI-I) scale.
  
  
  RESULTS
  The adjusted mean change in HAM-A scores from baseline was indicating a significant improvement over baseline in both treatment arms (p < 0.0001). The mean CGI-I scale score at week was with no significant difference between the two arms (p = 0.42). Rates of response were 48.6% for tandospirone and 55.6% for sertraline using the CGI-I. Response rates were 37.1% for tandospirone and 41.7% for sertraline using a HAM-A response criterion (≥50% reduction). The adjusted mean change in Social Phobia Inventory scores from baseline was indicating a significant improvement over baseline in both treatment arms (p < 0.0001).
  
  
  CONCLUSIONS
  Tandospirone is safe and effective and appears non-inferior to sertraline for SAD in youths.
authors: Department of Psychological Medicine, Zhongshan Hospital, Fudan University, Shanghai, China.
authors: Xiao
authors: X
authors: Huang
authors: Chao
authors: C
authors: Li
authors: Wei-Hui
authors: WH
authors: Li
authors: Yan-Li
authors: YL
authors: Luo
authors: Biao
authors: B
authors: Wang
authors: Wei
authors: W
authors: Zhang
authors: Jian-Jun
authors: JJ
authors: Gan
authors: Jian-Lin
authors: JL
authors: Ji
mesh_terms: D000293:Adolescent; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D054833:Isoindoles / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D010698:Phobic Disorders / Q000188:drug therapy*; D010879:Piperazines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D011743:Pyrimidines / Q000009:adverse effects / Q000627:therapeutic use*; D017366:Serotonin Receptor Agonists / Q000009:adverse effects / Q000627:therapeutic use; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014151:Anti-Anxiety Agents; D054833:Isoindoles; D010879:Piperazines; D011743:Pyrimidines; D017366:Serotonin Receptor Agonists; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; C055267:tandospirone
keywords: adolescent; anxiolytics; social anxiety disorder; tandospirone