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International Journal of Bipolar Disorders

Table 1 Demographics and baseline characteristics

From: A randomised, double-blind, placebo-controlled study to evaluate the safety and efficacy of lamotrigine in the maintenance treatment of Chinese adult patients with bipolar I disorder

Characteristic

Open-label phase

Double-blind phase

Lamotrigine

N = 420

Lamotrigine

N = 131

Placebo

N = 133

Total

N = 264

Age (years)

35.7 (11.7)

34.8 (10.9)

37.4 (12.5)

36.1 (11.8)

Gender, n (%)

    

 Women

220 (52.4)

75 (57.3)

62 (46.6)

137 (51.9)

 Men

200 (47.6)

56 (42.7)

71 (53.4)

127 (48.1)

BMI (kg/m2)

24.2 (3.8)

24.0 (3.9)

24.3 (3.8)

24.2 (3.9)

Weight (kg)

67.1 (12.8)

66.9 (13.8)

67.5 (11.9)

67.2 (12.8)

Duration of current episode (weeks)

7.6 (8.0)

7.8 (7.8)

7.7 (7.2)

7.8 (7.5)

Age at onset of first episode (years)

    

 Depression

29.5 (10.8)a

29.5 (9.7)b

30.7 (11.6)

30.1 (10.7)c

 Mixed/manic

30.4 (11.1)d

30.4 (10.2)e

31.3 (12.1)f

30.9 (11.1)c

Number of episodes in past 3 years

    

 Mania

1.1 (0.73)g

1.2 (0.68)

1.1 (0.70)f

1.1 (0.69)h

 Hypomania

0.1 (0.32)g

0.1 (0.24)

0.1 (0.44)f

0.1 (0.35)h

 Depression

1.2 (0.76)g

1.3 (0.81)

1.2 (0.76)f

1.2 (0.79)h

Index episode, n (%)

    

 Mania

152 (36)

43 (33)

52 (39)

95 (36)

 Hypomania

10 (2)

3 (2)

2 (2)

5 (2)

 Depression

237 (56)

81 (62)

72 (54)

153 (58)

 Mixed

21 (5)

4 (3)

7 (5)

11 (4)

HAMD score

11.1 (8.2)d

2.7 (3.0)e

2.3 (2.5)

2.5 (2.8)

YMRS score

6.7 (9.5)d

1.0 (2.0)e

0.8 (1.6)

0.9 (1.8)

Suicide attempts, n (%)

34 (8.1)

7 (5.3)

7 (5.3)

14 (5.3)

Concomitant psychiatric medications9, n (%)

    

Lithium carbonate

120 (28.6)

8 (6.1)

7 (5.3)

15 (5.7)

Valproate sodium

119 (28.3)

12 (9.2)

11 (8.3)

23 (8.7)

Olanzapine

78 (18.6)

8 (6.1)

9 (6.8)

17 (6.4)

Quetiapine fumarate

71 (16.9)

7 (5.3)

5 (3.8)

12 (4.5)

Quetiapine

69 (16.4)

8 (6.1)

7 (5.3)

15 (5.7)

Valproate magnesium

58 (13.8)

5 (3.8)

3 (2.3)

8 (3.0)

Clonazepam

48 (11.4)

1 (0.8)

6 (4.5)

7 (2.7)

Citalopram

31 (7.4)

3 (2.3)

5 (3.8)

8 (3.0)

Alprazolam

23 (5.5)

2 (1.5)

2 (1.5)

4 (1.5)

Aripiprazole

22 (5.2)

1 (0.8)

3 (2.3)

4 (1.5)

Paroxetine

22 (5.2)

1 (0.8)

0

1 (0.4)

Lamotrigine

4 (1.0)

13 (9.9)

16 (12.0)

29 (11.0)

  1. Data are presented as mean (SD), unless otherwise specified
  2. BMI, body mass index; HAMD, Hamilton Depression Scale; SD, standard deviation; YMRS, Young Mania Rating Scale
  3. Analysis population: safety population
  4. an = 415; bn = 129; cn = 262; dn = 416; en = 130; fn = 132; gn = 419; hn = 263; iMore than 5% in any group
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