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Table 1 Demographics, clinical characteristics, and disposition

From: Effects of asenapine on depressive symptoms in patients with bipolar I disorder experiencing acute manic or mixed episodes: a post hoc analysis of two 3-week clinical trials

 

Asenapine

(n = 379)*

Placebo

(n = 202)*

Olanzapine

(n = 396)*

Patient populations, n

   

   Patients with mixed episodes

111

67

124

   Patients with MADRS total score ≥20

45

33

54

   Patients with CGI-BP-D severity score ≥4§

59

37

74

Men, n (%)

   

   Patients with mixed episodes

63 (56.8)

30 (44.8)

70 (56.5)

   Patients with MADRS total score≥20

22 (48.9)

16 (48.5)

26 (48.1)

   Patients with CGI-BP-D severity score ≥4§

31 (52.5)

18 (48.6)

37 (50)

Mean ± SD age, y

   

   Patients with mixed episodes

38.3 ± 11.2

39.5 ± 12.5

38.8 ± 10.4

   Patients with MADRS total score ≥20

38.3 ± 11.5

41.2 ± 11.6

39.5 ± 11.1

   Patients with CGI-BP-D severity score ≥4§

39.4 ± 11.8

36.9 ± 12.7

39.6 ± 9.7

Mean ± SD daily dose, mg

   

   Patients with mixed episodes

18.2 ± 2.8

-

15.6 ± 2.3

   Patients with MADRS total score ≥20

18.3 ± 2.7

-

16.3 ± 2.5

   Patients with CGI-BP-D severity score ≥4§

17.9 ± 2.6

-

15.9 ± 2.5

Mean ± SD MADRS total score

   

   Patients with mixed episodes

16.7 ± 6.3

18.8 ± 7.3

16.9 ± 6.9

   Patients with MADRS total score ≥20

24.4 ± 3.5

25.8 ± 4.7

24.7 ± 4.4

   Patients with CGI-BP-D severity score ≥4§

20.2 ± 6.9

22.2 ± 7.5

19.7 ± 7.2

Mean ± SD CGI-BP-D severity score

   

   Patients with mixed episodes

3.1 ± 1.3

3.4 ± 1.1

3.2 ± 1.1

   Patients with MADRS total score ≥20

3.9 ± 0.9

3.8 ± 0.9

3.8 ± 0.8

   Patients with CGI-BP-D severity score ≥4§

4.4 ± 0.6

4.3 ± 0.5

4.2 ± 0.4

Discontinuations, n (%)

   

   Patients with mixed episodes, overall

44 (39.6)

24 (35.8)

31 (25.0)

Adverse events

12 (10.8)

1 (1.5)

7 (5.6)

Lack of efficacy

8 (7.2)

8 (11.9)

7 (5.6)

Lost to follow-up

2 (1.8)

1 (1.5)

6 (4.8)

Withdrew consent

20 (18.0)

12 (17.9)

11 (8.9)

Other

2 (1.8)

2 (3.0)

0 (0)

   Patients with MADRS total score ≥20, overall

19 (42.2)

11 (33.3)

13 (24.1)

Adverse events

6 (13.3)

1 (3.0)

2 (3.7)

Lack of efficacy

2 (4.4)

5 (15.2)

7 (13.0)

Lost to follow-up

2 (4.4)

0 (0)

1 (1.9)

Withdrew consent

8 (17.8)

4 (12.1)

3 (5.6)

Other

1 (2.2)

1 (3.0)

0 (0)

   Patients with CGI-BP-D severity score ≥4,§ overall

26 (44.1)

14 (37.8)

19 (25.7)

Adverse events

6 (10.2)

1 (2.7)

4 (5.4)

Lack of efficacy

4 (6.8)

4 (10.8)

8 (10.8)

Lost to follow-up

1 (1.7)

1 (2.7)

3 (4.1)

Withdrew consent

13 (22.0)

7 (18.9)

4 (5.4)

other

2 (3.4)

1 (2.7)

0 (0)

  1. CGI-BP-D = Clinical Global Impression for Bipolar Disorder-Depression scale; MADRS = Montgomery-Asberg Depression Rating Scale.
  2. *Total number of patients in the randomized treatment group in the original studies.
  3. Based on diagnosis at baseline (not post hoc assessment of MADRS or CGI-BP-D score)
  4. Data represent patients with a MADRS total score ≥20 regardless of baseline CGI-BP-D severity score.
  5. §Data represent patients with a CGI-BP-D severity score ≥4 at baseline regardless of baseline MADRS total score.