efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, multicenter, double-blind, placebo-controlled trial
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2015
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Abstract
Objectives. We aimed at evaluating both the efficacy and safety of TJ-54 (Yokukansan) in patients with treatment-resistant schizophrenia. This randomized, multicenter, double-blind, placebo-controlled study was conducted. Methods. One hundred and twenty antipsychotic-treated inpatients were included. Patients were randomized to adjuvant treatment with TJ-54 or placebo. During a 4-week follow-up, psychopathology was assessed using the Positive and Negative Syndrome Scale (PANSS). Results. TJ-54 showed a tendency of being superior to placebo in reduction total, positive, and general PANSS scores in treatment-resistant schizophrenia, 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 TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores for lack of spontaneity and flow of conversation (TJ-54: −0.23±0.08; placebo: −0.03±0.08, P<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: −0.07±0.10, P<0.037). Conclusions. The results of the present study indicate that TJ-54 showed a tendency of being superior to placebo in reduction PANSS scores in treatment-resistant schizophrenia, but the difference was not statistically significant. However, compared to the placebo group, TJ-54 group showed statistically significant improvements in the individual PANSS subscale scores.
| Reference Key |
miyaoka2015evidence-basedefficacy
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| Authors | ;Tsuyoshi Miyaoka;Motohide Furuya;Jun Horiguchi;Rei Wake;Sadayuki Hashioka;Masaya Thoyama;Kenta Murotani;Norio Mori;Yoshio Minabe;Masaomi Iyo;Shuichi Ueno;Sachiko Ezoe;Syuzo Hoshino;Haruo Seno |
| Journal | ACS applied materials & interfaces |
| Year | 2015 |
| DOI |
10.1155/2015/201592
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| URL | |
| Keywords |
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