[Efficacy and safety of tandospirone in the treatment of patients with anxiety disorder].

ABSTRACT

OBJECTIVE: To explore the efficacy and safety of tandospirone for adolescents with anxiety disorder. METHODS: In this multicenter open-label 12-week study, a total of 169 adolescents met the criteria of DSM-IV for anxiety disorder were treated with flexible dose of tandospirone. The effects and safety of treatment were assessed by the Hamilton anxiety scale (HAMA), state-trait anxiety inventory (STAI), clinical global impression (CGI) and side effects at baseline and Weeks 2, 4, 8 and 12. RESULTS: In 151 cases completing the 12-week treatment, the scores of HAMA decreased by 18% ± 12%, 38% ± 16%, 54% ± 20% and 63% ± 17% at Weeks 2, 4, 8 and 12. Significant reductions in HAMA scores were seen at Weeks 2-12 (P < 0.01) and marked improvement appeared in 81.5% cases at Week 12 (reduction rate of HAMA 50%). At Week 12, the HAMD(17) scores were markedly lower versus baseline (7 ± 2 vs 13 ± 3, P < 0.01). Adverse effect of tandospirone was scarcely found (9.9%). CONCLUSION: Tandospirone is an effective and safe anti-anxiety drug for adolescents.