Table 4.

Change in Mean Outcome Measure Scores during Phase II: Comparison of Participants Receiving Adjunctive Psychotropic Medications with Participants not Receiving Adjunctive Psychotropic Medications

	No adjunctive psychotropic medications n=16		Adjunctive psychotropic medications n=25		Mean difference in change scores
Measure	Total participants	p	Total participants	p	Mean (SD)	p
YMRS
Phase II baseline score Mean (SD)	8.2 (5.4)		10.8 (6.8)
EOS score Mean (SD)	8.7 (8.2)	0.76	9.9 (7.0)	0.56	1.4 (7.2)	0.55
Change score Mean (SD)	0.5 (6.8)		−0.9 (7.5)
CDRS-R
Phase II baseline score Mean (SD)	24.8 (5.1)		23.5 (5.4)
EOS score Mean (SD)	23.6 (7.1)	0.49	22.4 (5.7)	0.35	−0.2 (6.3)	0.93
Change score Mean (SD)	−1.2 (7.1)		−1.1 (5.7)
CGAS
Phase II baseline score Mean (SD)	67.5 (14.4)		69.7 (14.2)
EOS score Mean (SD)	69.2 (13.2)	0.48	68.9 (13.5)	0.55	0.5 (9.9)	0.86
Change score Mean (SD)	1.7 (9.8)		1.2 (10.0)
CGI-S (Mania)
Phase II baseline score Mean (SD)	2.2 (0.9)		2.4 (1.0)
EOS score Mean (SD)	2.2 (1.1)	1.00	2.2 (1.1)	0.46	0.2 (0.9)	0.60
Change score Mean (SD)	0 (0.7)		−0.2 (1.1)
CGI-S (Depression)
Phase II baseline score Mean (SD)	1.9 (1.0)		1.7 (0.8)
EOS score Mean (SD)	2.1 (0.9)	0.48	1.7 (0.9)	1.00	0.2 (1.0)	0.56
Change score Mean (SD)	0.2 (1.0)		0.0 (1.0)
CGI-S (Overall Illness)
Phase II baseline score Mean (SD)	2.4 (0.9)		2.4 (1.0)
EOS score Mean (SD)	2.2 (1.1)	0.42	2.2 (1.1)	0.38	0.0 (1.0)	0.97
Change score Mean (SD)	−0.2 (0.9)		−0.2 (1.1)

YMRS, Young Mania Rating Scale; CDRS-R, Child Depression Rating Scale Revised; CGAS, Children's Global Assessment Scale; CGI-S, Clinical Global Impressions-Severity; EOS, end of study.