Table 3.

Summary of Primary and Secondary End-Points at Week 6 of RCT

	Ziprasidone		Placebo		Difference from placebo		p value
End-point	n	LS mean (SE)	n	LS mean (SE)	LS mean (SE)	95% CI
mITT analysis set
BPRS-A Total Score	189	−14.2 (0.8)	87	−12.4 (1.1)	−1.8 (1.3)	−4.3 to 0.7	0.15
PANSS Total Score	183	−23.6 (1.4)	86	−21.0 (1.7)	−2.6 (2.0)	−6.5 to 1.4	0.20
PANSS Positive Subscale	183	−7.2 (0.4)	86	−5.9 (0.6)	−1.3 (0.7)	−2.6 to 0.1	0.04
PANSS Negative Subscale	183	−5.5 (0.4)	86	−5.1 (0.5)	−0.4 (0.6)	−1.6 to 0.7	0.47
CGI-S Score	190	−1.1 (0.1)	87	−0.8 (0.1)	−0.2 (0.1)	−0.5 to 0.1	0.13
CGI-I Score	190	2.7 (0.1)	87	2.9 (0.1)	−0.2 (0.1)	−0.5 to −0.1	0.18
PP analysis set
BPRS-A Total Score	141	−15.0 (0.9)	67	−11.7 (1.2)	−3.3 (1.5)	−6.2 to −0.4	0.03
PANSS Total Score	136	−24.1 (1.7)	67	−19.6 (2.1)	−4.5 (2.4)	−9.3 to 0.2	0.06
PANSS Positive Subscale	136	−7.3 (0.5)	67	−5.3 (0.7)	−2.0 (0.8)	−3.5 to −0.5	0.01
PANSS Negative Subscale	136	−5.8 (0.6)	67	−4.6 (0.6)	−1.2 (0.7)	−2.6 to 0.2	0.10
CGI-S Score	142	−1.2 (0.1)	68	−0.8 (0.1)	−0.3 (0.2)	−0.65 to 0.0	0.05
CGI-I Score	142	2.6 (0.1)	68	2.9 (0.1)	−0.3 (0.2)	−0.6 to 0.1	0.12

BPRS-A, Brief Psychiatric Rating Scale–Anchored; CGI-S, Clinical Global Impressions-Severity; CGI-I, Clinical Global Impressions-Improvement; CI, confidence interval; LS, least squares; mITT, modified intent-to-treat; PANSS, Positive and Negative Symptom Scale; PP, per protocol; RCT, randomized controlled trial; SE, standard error.