Efficacy and safety of yokukansan in treatment-resistant XXXX : a randomized, multicenter, double-blind, placebo-controlled trial.

@entity1 @entity15414 @entity161
Objectives. We aimed at evaluating both the efficacy and safety of @entity15414 (Yokukansan) in @entity1 with treatment-resistant @entity161 . This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. @entity1 were randomized to adjuvant treatment with @entity15414 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. @entity15414 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant @entity161 , but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT). However, in PPS analysis, compared to the placebo group, the @entity15414 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation ( @entity15414 : -0.23    0.08; placebo: -0.03    0.08, P < 0.018), tension ( @entity15414 : -0.42    0.09; placebo: -0.18    0.09, P < 0.045), and poor impulse control ( @entity15414 : -0.39    0.10; placebo: -0.07    0.10, P < 0.037). Conclusions. The results of the present study indicate that @entity15414 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant @entity161 , but the difference was not statistically significant. However, compared to the placebo group, @entity15414 group showed statistically significant improvements in the individual PANSS subscale scores.
