Table 3.

Body Weight and Fasting Lipid Parameters: Change Score from Pre-treatment Baseline during Open-label 10 to 16 Weeks Stabilization Phase

	Lithium + Ziprasidone		Valproate + Ziprasidone			Ziprasidone + Mood Stabilizers (MS) ‡
	Screening Baseline Mean (SD)	Change Score Mean (95% CI)	Screening Baseline Mean (SD)	Change Score Mean (95% CI)	Zip+Li vs. Zip+Val	Screening Baseline Mean (SD)	Change Score Mean (95% CI)	Zip + MS vs. Screening Baseline
Body Weight (kg)	n=225 78.6 (19.5)	n=225 0.23 (− 0.46, 0.91)	n=268 83.0 (22.6)	n=268 0.54 (− 0.09, 1.16)	P=0.513 F(1, 490) =0.43	n=507 81.0 (21.2)	n=507 0.39 (−0.06, 0.84)	P=0.09 t= 1.70 df=505
BMI	n=193 28.1 (6.0)	n=193 −0.08 (−0.27, 0.12)	n=228 29.1 (7.1)	n=228 0.12 (− 0.06, 0.29)	P=0.152 F(1, 418) = 2.06	n=433 28.6 (6.6)	n=433 0.04 (−0.09, 0.17)	P=0.554 t= 0.59 df=431
LDL Cholesterol (Fasting), mg/dL	n=148 107.5 (31.3)	n=148 −4.8 (− 8.3, − 1.4)	n=160 106.5 (31.6)	n=160 −3.3 (− 6.63, − 0.04))	P=0.530 F(1,305)=0.4	n=316 106.8 (31.3)	n=316 −4.24 (− 6.72, − 1.77)	P<0.001 t= −3.38 df=314
HDL Cholesterol (Fasting). mg/dL	n=152 50.5 (13.1)	n=152 −0.16 (−1.37, 1.04)	n=162 49.4 (16.3)	n=162 0.34 (− 0.82, 1.51)	P=0.553 F(1,311)=0.35	n=322 50.0 (14.8)	n=322 0.06 (− 0.83, 0.94)	P=0.90 t= 0.13 df=320
Cholesterol (Fasting), mg/dL	n=152 185.9 (40.4)	n=152 −4.30 (−8.23, − 0.37)	n=162 184.3 (41.0)	n=162 −3.48 (−7.28, 0.33)	P=0.767 F(1,311)=0.09	n=322 184.8 (40.5)	n=322 −4.2 (− 7.0, − 1.3)	P=0.004 t= −2.87, df=320
Triglycerides (fasting), mg/dL	n=146 138.3 (78.0)	n=146 4.40 (−6.27, 15.08)	n=161 142.1 (82.7)	n=161 −0.77 (−10.94, 9.39)	P=0.490 F(1,304)=0.48	n=315 139.5 (79.9)	n=315 1.32 (− 6.37, 9.00)	P=0.74 t= 1.316 df = 313
Glucose (Fasting), mg/dL	n=153 95.4 (24.7)	n=153 2.05 (−0.70, 4.79)	n=162 90.3 (24.5)	n=162 −1.85 (−4.52, 0.82)	P=0.047 F(1,312)=3.98	n=323 93.3 (27.1)	n=323 −0.7 (− 3.2, 1.9)	P=0.61 t= −0.52 df=321

^‡14 subjects had unspecified mood stabilizer information. P-values were reported before Bonferroni adjustment for multiplicity comparisons.