Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant\nschizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and\ntwenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo.\nDuring a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. TJ-\n54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant\nschizophrenia, but the difference was not statistically significant in both per-protocol set (PPS) and intention-to-treat (ITT).\nHowever, in PPS analysis, compared to the placebo group, the TJ-54 group showed statistically significant improvements in the\nindividual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: ?0.23 �± 0.08; placebo: ?0.03 �± 0.08,\nP < 0.018), tension (TJ-54: ?0.42 �± 0.09; placebo: ?0.18 �± 0.09, P < 0.045), and poor impulse control (TJ-54: ?0.39 �± 0.10; placebo:\n?0.07 �± 0.10, P < 0.037). Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior\nto placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant.\nHowever, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS\nsubscale scores.
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