Safety and efficacy of different initial doses of lurasidone in the schizophrenia treatment: A multi-center, randomized, open-label study

Table 5 Change from baseline to Visit 1-4 for efficacy measures (full analysis set and mixed model for repeated measurements analysis)

Scale	Visit	LS mean (SE)		Difference between groups
		Lurasidone (40 mg/day), n = 99	Lurasidone (80 mg/day), n = 98	LS difference (SE)	95%CI	P value1	P value2
PANSS total	Visit 1	-14.3 (1.41)	-17.0 (1.47)	2.7 (2.04)	-1.30 to 6.73	0.183	0.273
	Visit 2	-20.9 (1.64)	-25.4 (1.72)	4.5 (2.38)	-0.18 to 9.20	0.060	0.114
	Visit 3	-26.4 (1.81)	-30.6 (1.93)	4.2 (2.65)	-1.04 to 9.41	0.116	0.176
	Visit 4	-30.6 (1.92)	-34.2 (2.08)	3.7 (2.84)	-1.93 to 9.27	0.198	0.254
PANSS positive subscale	Visit 1	-4.1 (0.46)	-5.6 (0.48)	1.6 (0.67)	0.23-2.88	0.022a	0.143
	Visit 2	-6.7 (0.49)	-8.4 (0.52)	1.7 (0.72)	0.25-3.08	0.022a	0.063
	Visit 3	-8.6 (0.57)	-9.5 (0.61)	0.9 (0.83)	-0.77 to 2.52	0.294	0.581
	Visit 4	-9.7 (0.60)	-10.4 (0.65)	0.7 (0.88)	-1.02 to 2.46	0.416	0.708
PANSS negative subscale	Visit 1	-3.4 (0.43)	-3.5 (0.45)	0.1 (0.63)	-1.15 to 1.31	0.899	0.742
	Visit 2	-4.6 (0.52)	-5.8 (0.54)	1.2 (0.75)	-0.26 to 2.71	0.105	0.039
	Visit 3	-5.5 (0.56)	-6.7 (0.60)	1.3 (0.82)	-0.37 to 2.89	0.128	0.194
	Visit 4	-6.5 (0.62)	-8.2 (0.66)	1.7 (0.91)	-0.10 to 3.48	0.064	0.145
PANSS general psychopathology subscale	Visit 1	-6.8 (0.70)	-8.0 (0.73)	1.2 (1.01)	-0.80 to 3.19	0.239	0.298
	Visit 2	-9.5 (0.86)	-11.3 (0.90)	1.7 (1.24)	-0.74 to 4.16	0.169	0.424
	Visit 3	-12.3 (0.90)	-14.4 (0.96)	2.0 (1.32)	-0.55 to 4.65	0.121	0.225
	Visit 4	-14.3 (0.90)	-15.6 (0.98)	1.2 (1.33)	-1.39 to 3.87	0.353	0.446
Positive factor score	Visit 1	-2.3 (0.28)	-3.0 (0.29)	0.7 (0.40)	-0.06 to 1.52	0.071	0.599
	Visit 2	-4.0 (0.31)	-5.0 (0.33)	1.0 (0.45)	0.14-1.92	0.024a	0.199
	Visit 3	-5.3 (0.37)	-5.7 (0.40)	0.4 (0.55)	-0.64 to 1.53	0.419	0.923
	Visit 4	-6.1 (0.38)	-6.3 (0.42)	0.2 (0.57)	-0.94 to 1.30	0.754	0.672
Negative factor score	Visit 1	-3.3 (0.42)	-3.1 (0.44)	-0.2 (0.61)	-1.42 to 0.99	0.727	0.932
	Visit 2	-3.9 (0.52)	-5.0 (0.54)	1.1 (0.75)	-0.42 to 2.54	0.161	0.065
	Visit 3	-4.9 (0.56)	-5.9 (0.59)	1.0 (0.82)	-0.61 to 2.61	0.222	0.242
	Visit 4	-5.9 (0.59)	-7.4 (0.63)	1.5 (0.87)	-0.20 to 3.23	0.082	0.155
Cognitive scale score	Visit 1	-1.1 (0.20)	-1.6 (0.20)	0.6 (0.28)	-0.01 to 1.11	0.054	0.029a
	Visit 2	-1.8 (0.23)	-2.6 (0.24)	0.8 (0.33)	0.14-1.44	0.018a	0.008a
	Visit 3	-2.1 (0.24)	-3.2 (0.25)	1.1 (0.35)	0.38-1.76	0.002a	0.003a
	Visit 4	-2.4 (0.24)	-3.5 (0.26)	1.1 (0.36)	0.38-1.80	0.003a	0.003a
Excitation scale score	Visit 1	-2.1 (0.31)	-3.1 (0.33)	1.0 (0.45)	0.07-1.85	0.035a	0.119a
	Visit 2	-2.9 (0.31)	-3.8 (0.33)	0.9 (0.45)	0.00-1.79	0.051	0.168
	Visit 3	-3.6 (0.26)	-4.4 (0.28)	0.8 (0.38)	0.04-1.56	0.040a	0.274
	Visit 4	-3.7 (0.34)	-4.2 (0.37)	0.5 (0.50)	-0.50 to 1.48	0.330	0.326
Depression and anxiety scale score	Visit 1	-1.2 (0.16)	-1.3 (0.17)	0.1 (0.23)	-0.32 to 0.60	0.551	0.878
	Visit 2	-1.7 (0.18)	-1.6 (0.19)	-0.1 (0.27)	-0.60 to 0.45	0.781	0.517
	Visit 3	-2.1 (0.18)	-2.0 (0.20)	-0.1 (0.27)	-0.64 to 0.43	0.698	0.384
	Visit 4	-2.2 (0.19)	-2.0 (0.21)	-0.2 (0.28)	-0.76 to 0.34	0.451	0.226
CGI-S	Visit 1	-0.6 (0.12)	-0.9 (0.12)	0.2 (0.17)	-0.10 to 0.57	0.165	0.525
	Visit 2	-1.0 (0.11)	-1.4 (0.12)	0.3 (0.16)	0.01-0.66	0.044a	0.433
	Visit 3	-1.6 (0.13)	-1.8 (0.14)	0.3 (0.19)	-0.12 to 0.64	0.178	0.721
	Visit 4	-1.9 (0.14)	-2.1 (0.15)	0.2 (0.20)	-0.19 to 0.62	0.298	0.920
CDSS	Visit 1	-1.5 (0.20)	-1.2 (0.21)	-0.4 (0.29)	-0.95 to 0.21	0.213	0.029a
	Visit 2	-1.9 (0.22)	-1.3 (0.23)	-0.6 (0.32)	-1.22 to 0.05	0.072	0.050
	Visit 3	-2.0 (0.22)	-1.5 (0.24)	-0.5 (0.33)	-1.13 to 0.16	0.142	0.035a
	Visit 4	-2.3 (0.22)	-1.4 (0.24)	-0.9 (0.32)	-1.52 to -0.25	0.006a	0.031a

¹P values were derived from the Mixed Model for Repeated Measures model, in which fixed effects included treatment, visit, and treatment-visit interaction effects. Covariates were the baseline values, and random effects were the participants.

²P values were used to compare differences in change from baseline between the two groups at each visit point using either a paired t-test or Wilcoxon paired signed-ranks test. Missing values were imputed using the last observation carried forward approach.

^aP < 0.05 vs lurasidone (40 mg/day).

PANSS: Positive and Negative Syndrome Scale; CGI-S: Clinical Global Impression Scale-Severity; CDSS: Calgary Depression Scale for Schizophrenia; LS: Least squares; CI: Confidence interval; SE: Standard error.