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Table 2 Summary of mean changes from baseline in depressive symptoms for randomized patients

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

Placebo

Olanzapine

  

Mean ± SD

P value

Mean ± SD

P value

Mean ± SD

P value

MADRS total score

       

Patients with mixed episodes

at baseline

Baseline

16.7 ± 6.3

 

18.8 ± 7.3

 

16.9 ± 6.9

 
 

Change at day 7

-6.3 ± 6.5

<0.0001

-4.4 ± 8.0

0.0011

-4.9 ± 5.3

<0.0001

 

Change at day 21

-8.2 ± 7.6

<0.0001

-7.1 ± 8.2

<0.0001

-6.8 ± 7.0

<0.0001

Patients with MADRS total

score ≥20 at baseline*

Baseline

24.4 ± 3.5

 

25.8 ± 4.7

 

24.7 ± 4.4

 
 

Change at day 7

-11.0 ± 7.6

<0.0001

-4.7 ± 9.5

0.0255

-6.9 ± 6.7

<0.0001

 

Change at day 21

-12.9 ± 8.6

<0.0001

-8.4 ± 9.6

0.0007

-10.3 ± 8.8

<0.0001

Patients with CGI-BP-D

severity score ≥4 at baseline†

Baseline

20.2 ± 6.9

 

22.2 ± 7.5

 

19.7 ± 7.2

 
 

Change at day 7

-7.5 ± 8.3

<0.0001

-4.1 ± 7.8

0.0188

-5.5 ± 5.2

<0.0001

 

Change at day 21

-9.8 ± 8.6

<0.0001

-6.9 ± 10.7

0.0064

-8.2 ± 6.5

<0.0001

CGI-BP-D severity score

       

Patients with mixed episodes

at baseline

Baseline

3.1 ± 1.3

 

3.4 ± 1.1

 

3.2 ± 1.1

 
 

Change at day 7

-0.6 ± 0.9

<0.0001

-0.4 ± 1.1

0.0377

-0.7 ± 0.8

<0.0001

 

Change at day 21

-1.0 ± 1.3

<0.0001

-0.8 ± 1.3

0.0004

-0.9 ± 1.1

<0.0001

   Patients with MADRS total scores≥20 at baseline*

Baseline

3.9 ± 0.9

 

3.8 ± 0.9

 

3.8 ± 0.8

 
 

Change at day 7

-1.0 ± 1.0

<0.0001

-0.3 ± 1.2

0.1754

-0.8 ± 0.7

<0.0001

 

Change at day 21

-1.5 ± 1.4

<0.0001

-0.7 ± 1.2

0.0228

-1.2 ± 1.2

<0.0001

Patients with CGI-BP-D

severity score ≥4 at baseline†

Baseline

4.4 ± 0.6

 

4.3 ± 0.5

 

4.2 ± 0.4

 
 

Change at day 7

-1.2 ± 0.8

<0.0001

-0.6 ± 1.1

0.0127

-1.0 ± 0.9

<0.0001

 

Change at day 21

-1.7 ± 1.2

<0.0001

-1.2 ± 1.1

0.0001

-1.6 ± 1.1

<0.0001

PANSS Marder anxiety/depression factor score

      

   Patients with mixed episodes at baseline

Baseline

12.9 ± 3.6

 

13.5 ± 3.5

 

12.6 ± 3.6

 
 

Change at day 7

-2.2 ± 3.5

<0.0001

-1.5 ± 3.6

0.0125

-1.7 ± 2.7

<0.0001

 

Change at day 21

-3.4 ± 3.7

<0.0001

-3.0 ± 2.9

<0.0001

-2.8 ± 3.0

<0.0001

Patients with MADRS total

score ≥20 at baseline*

Baseline

14.4 ± 3.3

 

14.5 ± 2.7

 

14.7 ± 3.1

 
 

Change at day 7

-3.7 ± 3.6

<0.0001

-0.9 ± 2.4

0.0784

-1.8 ± 3.0

0.0004

 

Change at day 21

-4.9 ± 4.2

<0.0001

-2.4 ± 2.4

0.0002

-3.4 ± 3.7

<0.0001

Patients with CGI-BP-D

severity score ≥4 at baseline†

Baseline

13.8 ± 3.7

 

14.5 ± 2.9

 

13.5 ± 3.7

 
 

Change at day 7

-2.8 ± 3.3

<0.0001

-1.1 ± 2.2

0.0243

-1.5 ± 3.2

0.001

 

Change at day 21

-3.2 ± 4.5

0.0003

-2.4 ± 2.8

0.0007

-3.2 ± 3.4

<0.0001

  1. CGI-BP-D = Clinical Global Impression for Bipolar Disorder-Depression scale; MADRS = Montgomery-Asberg Depression Rating Scale; PANSS = Positive and Negative Syndrome Scale.
  2. P values are based on a two-sided t-test of within-subject mean changes from baseline.
  3. *Data represent patients with a MADRS total score ≥20 regardless of baseline CGI-BP-D severity score.
  4. †Data represent patients with a CGI-BP-D severity score ≥4 at baseline regardless of baseline MADRS total score.
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BMC Psychiatry

ISSN: 1471-244X

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