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Table 2 Stage 2 BDM Response Profile Mixed Model Repeated Measures

From: NRX-101 (D-cycloserine plus lurasidone) vs. lurasidone for the maintenance of initial stabilization after ketamine in patients with severe bipolar depression with acute suicidal ideation and behavior: a randomized prospective phase 2 trial

Populations

Day

lurasidone

(N = 5)

NRX-101

(N = 12)

NRX-101 - lurasidone

(N = 17)

LSMean

LSMean

LSDifference

(p-value)

No LOCF

2

2.4

3.0

0.6 (0.83)

 

7

4.6

1.7

-2.9 (0.36)

 

14

12.9

2.0

-10.9 (0.002)

 

21

5.7

5.5

-0.2 (0.95)

 

28

7.7

4.0

-3.7 (0.30)

 

BDM 10 Response Profile p-value

  

0.042

 

35

7.3

3.3

-4.0 (0.29)

 

42

7.7

4.9

-2.8 (0.46)

 

BDM 10 Response Profile p-value

  

0.09

LOCF

2

2.4

3.0

0.6 (0.85)

 

7

4.8

2.0

-2.8 (0.39)

 

14

11.4

2.2

-9.2 (0.006)

 

21

10.0

4.5

-5.5 (0.09)

 

28

11.2

3.5

-7.7 (0.02)

 

BDM 10 Response Profile p-value

  

0.04

 

35

10.8

2.8

-8.0 (0.02)

 

42

11.0

3.7

-7.3 (0.04)

 

BDM 10 Response Profile p-value

  

0.03

  1. BDM = BISS-derived MADRS score; ITT1 = Intent-to-Treat Stage 1 Population; ITT2 = Intent-to-Treat Stage 2 Population; LOCF = Last Observation Carried Forward