title: Efficacy and safety of yokukansan in treatment-resistant schizophrenia: a randomized, multicenter, double-blind, placebo-controlled trial.
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.
authors.affiliation: Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan.
authors.forename: Tsuyoshi
authors.identifier: 0000-0002-7467-4206
authors.initials: T
authors.lastname: Miyaoka
authors.affiliation: Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan.
authors.forename: Motohide
authors.initials: M
authors.lastname: Furuya
authors.affiliation: Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan.
authors.forename: Jun
authors.initials: J
authors.lastname: Horiguchi
authors.affiliation: Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan.
authors.forename: Rei
authors.identifier: 0000-0001-9248-9250
authors.initials: R
authors.lastname: Wake
authors.affiliation: Department of Psychiatry, Shimane University School of Medicine, Izumo, Japan.
authors.forename: Sadayuki
authors.initials: S
authors.lastname: Hashioka
authors.affiliation: Research Institute of Traditional Asian Medicine, Kinki University, Higashi-Osaka, Japan.
authors.forename: Masaya
authors.initials: M
authors.lastname: Thoyama
authors.affiliation: Center for Advance Medicine and Clinical Research, Nagoya University Hospital, Nagoya, Japan.
authors.forename: Kenta
authors.initials: K
authors.lastname: Murotani
authors.affiliation: Psychiatry & Neurology, Hamamatsu University School of Medicine, Hamamatsu, Japan.
authors.forename: Norio
authors.initials: N
authors.lastname: Mori
authors.affiliation: Psychiatry, Kanazawa University School of Medicine, Kanazawa, Japan.
authors.forename: Yoshio
authors.initials: Y
authors.lastname: Minabe
authors.affiliation: Psychiatry, Chiba University School of Medicine, Chiba, Japan.
authors.forename: Masaomi
authors.initials: M
authors.lastname: Iyo
authors.affiliation: Psychiatry, Ehime University School of Medicine, Matsuyama, Japan.
authors.forename: Shuichi
authors.initials: S
authors.lastname: Ueno
authors.affiliation: Medical Center for Translational Research, Osaka University Hospital, Suita, Japan.
authors.forename: Sachiko
authors.initials: S
authors.lastname: Ezoe
authors.affiliation: Psychiatry, Takeda General Hospital, Fukushima, Japan.
authors.forename: Syuzo
authors.initials: S
authors.lastname: Hoshino
authors.affiliation: Psychiatry, Matsue Aoba Hospital, Matsue, Japan.
authors.forename: Haruo
authors.initials: H
authors.lastname: Seno