Table 2.
Stage 2 BDM Response Profile Mixed Model Repeated Measures
| 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 |
BDM = BISS-derived MADRS score; ITT1 = Intent-to-Treat Stage 1 Population; ITT2 = Intent-to-Treat Stage 2 Population; LOCF = Last Observation Carried Forward