Yokukansan (TJ-54) for Irritability Associated with Pervasive Developmental Disorder in Children and Adolescents: A 12-Week Prospective, Open-Label Study

Abstract

These preliminary data suggest that TJ-54 may be effective and well tolerated for the treatment of severe irritability/agitation and hyperactivity/noncompliance in children and adolescents ages 6-17 years with PDD. However, given the characteristics of this trial, the present findings should be taken cautiously, and larger-scale placebo-controlled studies are needed to elucidate the efficacy and tolerability of TJ-54 in this understudied population.