A double-blind, placebo-controlled comparator study of LY2140023 monohydrate in patients with schizophrenia

BMC Psychiatry

Table 4 Primary analysis mixed-model repeated measures at visit 9 – PANSS total score in efficacy-evaluable ITT patients

Population	Treatment	N	LS Mean change	LS Mean change vs. placebo [1-Sided p-value]	Significance level (α, 1-sided)	Result of significance test (S/NS)
Overall population	PBO	253	−7.9
	RIS	124	−16.6	−8.7 [<.001]*	0.05*	Validity: S
	LY80	229	−7.1	0.8 [0.698]	0.01	Step 1: NS
	LY40	251	−9.4	−1.5 [0.154]	0.01	Step 2: NS
Predefined subpopulation	PBO	184	−7.2
	RIS	87	−16.3	−9.1 [<.001]*	0.05*	Validity: S
	LY80	160	−6.4	0.8 [0.659]	0.0025	Step 1: NS
	LY40	178	−10.5	−3.3 [0.033]	0.0025	Step 2: NS

Abbreviations: ITT intent-to-treat, LSMean least-squares mean, NS not significant, PANSS Positive and Negative Syndrome Scale, S significant.
Groups: PBO = placebo; LY40 = LY2140023 monohydrate 40 mg; LY80 = LY2140023 monohydrate 80 mg; RIS = risperidone.
*For the risperidone group, the 2-sided p-value and significance level were used.

ISSN: 1471-244X