Table 2.

Efficacy endpoints: change at week 6 (ITT population; MMRM)

	Placebo	Lurasidone 20 mg/day	Lurasidone 60 mg/day	Treatment Difference
	(N = 49)	(N = 48)	(N = 51)	LUR-20 versus PBO (95 % CI)	p	LUR-60 versus PBO (95 % CI)	p
ABC irritability/agitation
Baseline mean (SD)	29.1 (6.9)	28.3 (5.9)	27.1 (5.7)	−1.3 (−5.6, 3.0)	0.55	−1.9 (−6.1, 2.2)	0.36
LS mean change (SE)	−7.5 (1.5)	−8.8 (1.5)	−9.4 (1.4)
ABC Hyperactivity, baseline
Baseline mean (SD)	34.0 (9.2)	32.5 (8.7)	31.2 (11.3)	−2.5 (−6.8, 1.7)	0.24	+0.5 (−3.6, 4.6)	0.81
LS mean change (SE)	−7.1 (1.5)	−9.7 (1.5)	−6.6 (1.4)
ABC stereotypic behavior
Baseline mean (SD)	9.3 (6.3)	8.9 (5.2)	8.2 (5.1)	−1.1 (−3.0, 0.8)	0.26	+0.9 (−0.9, 2.8)	0.31
LS mean change (SE)	−2.6 (0.7)	−3.7 (0.7)	−1.6 (0.6)
ABC inappropriate speech
Baseline mean (SD)	7.2 (3.3)	6.8 (3.3)	6.5 (3.3)	+0.2 (−1.0, 1.4)	0.76	+0.1 (−1.1, 1.3)	0.87
LS mean change (SE)	−1.6 (0.4)	−1.4 (0.4)	−1.5 (0.4)
ABC lethargy/withdrawal
Baseline mean (SD)	18.7 (10.8)	15.2 (9.8)	17.4 (10.1)	−0.3 (−3.4, 2.8)	0.86	−0.9 (−3.9, 2.1)	0.55
LS mean change (SE)	−6.5 (1.1)	−6.8 (1.1)	−7.4 (1.0)
CGI-severity
Baseline mean (SD)	5.0 (0.8)	4.9 (0.8)	4.7 (0.8)	−0.3 (−0.8, 0.2)	0.18	−0.3 (−0.8, 0.2)	0.24
LS mean change (SE)	−0.7 (0.2)	−1.1 (0.2)	−1.0 (0.2)
CGI-improvementa
LS mean at week 6 (SE)	3.4 (0.2)	2.8 (0.2)	3.1 (0.2)	−0.6 (−1.1, −0.0)	0.035	−0.3 (−0.8, 0.2)	0.27
CY-BOCS Compulsions
Baseline mean (SD)	12.9 (4.6)	10.7 (5.7)	10.6 (5.7)	0.2 (−1.2, 1.5)	0.82	0.2 (−1.1, 1.5)	0.73
LS mean change (SE)	−1.2 (0.5)	−1.0 (0.5)	−1.0 (0.4)
CGSQ global strain, baseline
Baseline mean (SD)	10.0 (1.8)	9.3 (2.5)	9.5 (2.0)	−0.1 (−1.0, 0.7)	0.75	−0.3 (−1.1, 0.5)	0.45
LS mean change (SE)	−1.4 (0.3)	−1.5 (0.3)	−1.7 (0.3)

MMRM mixed model for repeated measures, ABC aberrant behavior checklist, CGI clinical global impression, CY-BOCS Children’s Yale-Brown Obsessive–Compulsive Scale, CGSQ caregiver strain questionnaire, CI confidence interval, LUR lurasidone, PBO placebo

^aTotal sccore (not change score)