Efficacy and Safety of Yokukansan in Treatment-Resistant Schizophrenia: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial
Table 3
Changes in efficacy measures from baseline to week 4 as determined by mixed-model repeated-measurements analysis (per-protocol set and intention-to-treat).
TJ-54
Placebo
n = 48
n = 50
PPS
PANSS (total)
−7.04 ± 1.59
−4.62 ± 1.53
ns
PANSS (positive)
−2.40 ± 0.59
−1.75 ± 0.56
ns
PASS (negative)
−1.28 ± 0.37
−0.88 ± 0.35
ns
PANSS (general)
−3.39 ± 0.36
−2.09 ± 0.34
ns
PANSS (N6 item)
−0.23 ± 0.08
0.03 ± 0.08
<0.018*
PANSS (G4 item)
−0.42 ± 0.09
−0.18 ± 0.09
<0.045*
PASS (G14 item)
−0.39 ± 0.10
−0.07 ± 0.10
<0.037*
CGI-S
−0.36 ± 0.09
−0.25 ± 0.07
ns
GAF
2.94 ± 0.70
2.82 ± 0.86
ns
DIEPSS
−0.57 ± 0.21
−0.68 ± 0.19
ns
n = 54
n = 60
ITT
PANSS (total)
−7.12 ± 1.70
−6.47 ± 1.54
ns
PANSS (positive)
−2.66 ± 0.56
−2.35 ± 0.57
ns
PASS (negative)
−1.29 ± 0.41
−1.13 ± 0.39
ns
PANSS (general)
−3.47 ± 0.91
−2.82 ± 0.39
ns
PANSS (N6 item)
−0.25 ± 0.09
−0.01 ± 0.09
<0.021*
PANSS (G4 item)
−0.43 ± 0.10
−0.22 ± 0.09
<0.048*
PASS (G14 item)
−0.42 ± 0.11
−0.15 ± 0.10
<0.028
CGI-S
−0.35 ± 0.09
−0.26 ± 0.08
ns
GAF
2.98 ± 0.95
2.63 ± 0.72
ns
DIEPSS
−0.54 ± 0.19
−0.57 ± 0.14
ns
Absolute values are given as scores at week 0 (baseline) minus those at week 4 (endpoint) (positive values indicate improvement). Data are not adjusted for baseline differences. *Significantly different. PANSS: Positive and Negative Syndrome Scale; CGI-S: Clinical Global Impression-Severity; GAF: Global Assessment of Functioning; DIEPSS: Drug Induced Extrapyramidal Symptoms Scale. PPS: per-protocol set; ITT: intention-to-treat.
