. 2019 Oct 22;322(16):1561–1569. doi: 10.1001/jama.2019.14685

Table 2. Comparison of Outcomes at 16 Weeks With a Complete Case Analysis.

	Mean (SD) [No.]				Primary Analysis^a		Secondary Analysis^b
	Fluoxetine		Placebo		Primary Analysis^a		Secondary Analysis^b
	Baseline	16 Weeks	Baseline	16 Weeks	Mean Difference (95% CI)	P Value	Mean Difference (95% CI)	P Value
CYBOCS-PDD^c	12.80 (3.41) [75]	9.02 (4.84) [54]	13.13 (3.36) [71]	10.89 (4.92) [55]	−2.01 (−3.77 to −0.25)	.03	−1.17 (−3.01 to 0.67)	.21
RBS^d
Total items	20.75 (9.67) [75]	16.89 (9.35) [53]	24.08 (10.01) [71]	21.64 (11.69) [53]	−5.06 (−9.15 to −0.97)	.02	−1.01 (−4.83 to 2.81)	.60
Total score	36.79 (22.86) [75]	27.09 (21.60) [54]	45.90 (24.26) [71]	36.40 (24.61) [53]	−9.93 (−18.74 to −1.12)	.03	−1.64 (−9.69 to 6.42)	.69
Spence Children’s Anxiety total^e	31.24 (21.72) [74]	20.58 (18.17) [53]	32.17 (20.15) [71]	24.70 (17.11) [53]	−4.04 (−10.75 to 2.66)	.23	−2.86 (−7.94 to 2.21)	.27
Verbal subgroup^f	32.59 (21.55) [70]	21.76 (18.40) [49]	33.63 (20.18) [65]	24.08 (17.04) [50]	−2.35 (−9.39 to 4.69)	.51	−2.37 (−7.63 to 2.88)	.37
ABC^g
I, irritability	18.57 (10.00) [75]	12.28 (9.19) [53]	17.87 (11.80) [71]	13.34 (11.29) [53]	−1.54 (−5.47 to 2.39)	.44	−0.39 (−3.87 to 3.09)	.82
II, lethargy	12.57 (8.03) [75]	9.49 (6.77) [53]	16.80 (10.60) [71]	13.85 (9.32) [53]	−4.41 (−7.61 to −1.21)	.007	−0.67 (−3.69 to 2.35)	.66
III, stereotypy	6.05 (4.91) [75]	5.08 (4.50) [53]	7.20 (5.63) [71]	5.08 (4.57) [53]	−0.21 (−1.85 to 1.42)	.80	0.62 (−0.99 to 2.22)	.45
IV, hyperactivity	21.71 (11.11) [75]	16.21 (10.48) [53]	21.28 (11.51) [71]	17.60 (12.52) [53]	−2.09 (−6.38 to 2.21)	.34	−0.92 (−4.70 to 2.86)	.63
V, inappropriate speech	4.48 (3.65) [75]	3.60 (3.18) [53]	4.80 (3.37) [71]	4.04 (3.44) [53]	−0.52 (−1.78 to 0.73)	.41	0.61 (−0.50 to 1.73)	.28
CGI^h
Severity of illness		3.25 (1.13) [55]		3.26 (1.15) [53]	−0.09 (−0.45 to 0.26)	.60	−0.03 (−0.41 to 0.35)	.88
Global improvement		3.22 (1.12) [55]		3.38 (1.10) [53]	−0.18 (−0.61 to 0.24)	.40	−0.18 (−0.66 to 0.30)	.46
Efficacy index		9.76 (3.97) [55]		10.69 (3.17) [54]	−0.97 (−2.33 to 0.38)	.16	−0.80 (−2.30 to 0.71)	.30
Disruptiveness assessment, totalⁱ	3.95 (2.24) [74]	2.98 (2.14) [43]	4.40 (2.16) [70]	3.69 (2.09) [49]	−0.76 (−1.59 to 0.08)	.08	−0.06 (−0.82 to 0.71)	.89

Abbreviations: ABC, Aberrant Behavior Checklist; CGI, Clinical Global Impression Scale; CYBOCS-PDD, Children’s Yale-Brown Obsessive Compulsive Scale–modified for pervasive developmental disorders; RBS, Repetitive Behavior Scale.

^{^a}

Results for the primary analysis are adjusted for site, age (8 to < 12 years and 12 to 18 years), and intellectual ability (IQ ≥ 70 and IQ < 70), as used in randomization.

^{^b}

Secondary analysis was in accordance with the primary analysis but also adjusted for sex, verbal vs nonverbal, baseline measure of the outcome of interest, baseline measures of RBS total items, RBS total score, and ABC II, lethargy.

^{^c}

CYBOCS-PDD range was 0 to 20, with higher scores indicating higher severity.

^{^d}

RBS total items range was 0 to 43; and total score range, 0 to 129. Higher scores indicate higher severity.

^{^e}

Range was 0 to 114, with higher scores indicating higher severity.

^{^f}

Because of the small sample in the nonverbal subgroup (9 participants at baseline, of whom 7 provided data at 16 weeks), the analysis of the Spence Children’s Anxiety Scale was conducted only on the verbal subgroup.

^{^g}

ABC irritability range was 0 to 45; lethargy/social withdrawal range, 0 to 48; stereotypic behavior range, 0 to 21; hyperactivity/noncompliance range, 0 to 48; and inappropriate speech range, 0 to 12. Higher scores indicate higher severity.

^{^h}

CGI severity of illness range was 0 to 7; global improvement range, 0 to 7; and efficacy index range, 1 to 16. Higher scores are associated with worsening of the condition.

^ⁱ

Disruptiveness assessment: range was 0 to 10, with higher scores indicating greater severity.