Table 4.
Week 6 | Week 12 | ||||||
Endpoint | Baseline Score | change from baseline | p value (change from baseline) | p value (between group difference) | change from baseline | p value (change from baseline) | p value (between group difference) |
Emotional | |||||||
HAM-A | |||||||
MMFS-01 | 17.1 ± 3.0 | –6.3 ± 3.6 | <0.001*** | 0.876 | –7.3 ± 5.8 | <0.001*** | 0.396 |
Placebo | 17.2 ± 2.5 | –6.1 ± 3.4 | <0.001*** | –8.6 ± 4.1 | <0.001*** | ||
PANAS: Positive Affect | |||||||
MMFS-01 | 28.3 ± 6.6 | 4.7 ± 5.2 | <0.001*** | 0.648 | 3.9 ± 7.0 | 0.014* | 0.596 |
Placebo | 27.7 ± 8.1 | 3.8 ± 8.1 | 0.046* | 5.1 ± 8.2 | 0.01* | ||
PANAS: Negative Affect | |||||||
MMFS-01 | 24.8 ± 6.4 | –7.6 ± 7.5 | <0.001*** | 0.556 | –8.3 ± 8.9 | 0.001** | 0.371 |
Placebo | 23.9 ± 6.0 | –6.3 ± 5.9 | <0.001*** | –6.4 ± 9.0 | 0.008** | ||
Sleep | |||||||
PSQI | |||||||
MMFS-01 | 13.7 ± 2.6 | –4.2 ± 3.8 | <0.001*** | 0.415 | –4.8 ± 4.5 | <0.001*** | 0.279 |
Placebo | 12.9 ± 2.4 | –3.2 ± 3.7 | <0.001*** | –6.1 ± 3.3 | <0.001*** |
Mean ± SEM. *significant p < 0.05. **significant p < 0.01. ***significant p < 0.001.