Table 1 Baseline demographic and clinical characteristics (safety set)

Age (years)

 Mean (SD)

37.9 (12.7)

38.8 (12.1)

38.3 (12.4)

 Median

37.0

38.0

37.0

 Range (min, max)

18, 64

18, 65

18, 65

Gender, n (%)

 Male

101 (58.4)

121 (66.1)

222 (62.4)

 Female

72 (41.6)

62 (33.9)

134 (37.6)

Race, n (%)

 White

98 (56.6)

102 (55.7)

200 (56.2)

 Asian

73 (42.2)

78 (42.6)

151 (42.4)

 Other

2 (1.2)

3 (1.6)

5 (1.4)

Weight (kg)

 Mean (SD)

69.1 (15.9)

71.0 (17.1)

70.1 (16.5)

 Median

68.0

69.0

68.0

 Range (min, max)

37, 120

37, 115

37, 120

BMI (kg/m²)

 Mean (SD)

24.3 (4.3)

24.9 (5.2)

24.6 (4.8)

 Median

23.8

24.1

23.9

 Range (min, max)

15.8, 37.1

14.7, 43.8

14.7, 43.8

Psychiatric diagnosis, n (%)

 Most recent episode manic

159 (91.8)

173 (94.5)

332 (93.3)

 Most recent episode mixed

14 (8.1)

10 (5.5)

24 (6.7)

Rapid cycling, n (%)

 Yes

3 (1.7)

5 (2.7)

8 (2.2)

 No

170 (98.3)

178 (97.3)

348 (97.8)

Time since first diagnosis of acute mania, years

 Mean (SD)

7.1 (6.6)

7.8 (7.0)

7.5 (6.8)

Time since first mania/mixed episode, years

 Mean (SD)

7.2 (6.6)

8.1 (7.0)

7.7 (6.8)

Total number of mania/mixed episodes in the past year, n (%)

 0

56 (32.4)

56 (30.6)

112 (31.5)

 1

88 (50.9)

88 (48.1)

176 (49.4)

 ≥ 2

29 (16.8)

39 (21.3)

68 (19.1)

Previous medication use, n (%)

 Lithium

4 (2.3)

2 (1.1)

6 (1.7)

 Quetiapine

8 (4.6)

17 (9.3)

25 (7.0)