Table 1.
Summary of Change from Baseline Depression Scores at Week 3 and Week 6 (Full Analysis Set)
| Baseline | Timepoint | Change from Baseline | Difference (Filorexant vs. Placebo) | ||||
|---|---|---|---|---|---|---|---|
| Assessment | N | Mean (SD) | Mean (SD) | Mean (SD) | LS mean (95% CI) | LS mean (95% CI) | P value |
| MADRS total score (primary endpoint) | |||||||
| Week 3 | |||||||
| Filorexant 10 mg | 61 | 30.2 (4.6) | 23.2 (8.0) | -7.0 (6.2) | -7.0 (-8.7, -5.3) | -0.3 (-2.7, 2.0) | 0.770 |
| Placebo | 62 | 30.9 (4.4) | 24.3 (8.1) | -6.6 (6.9) | -6.6 (-8.3, -5.0) | ||
| Week 6 | |||||||
| Filorexant 10 mg | 58 | 30.3 (4.6) | 19.3 (9.7) | -11.0 (9.5) | -10.9 (-13.2, -8.7) | -0.7 (-3.8, 2.5) | 0.679 |
| Placebo | 61 | 31.0 (4.3) | 20.7 (8.7) | -10.3 (8.2) | -10.3 (-12.5, -8.0) | ||
| MADRS score excluding sleep item | |||||||
| Week 3 | |||||||
| Filorexant 10 mg | 61 | 26.4 (4.2) | 20.4 (7.6) | -6.0 (5.8) | -6.0 (-7.5, -4.4) | -0.2 (-2.4, 1.9) |
0.831 |
| Placebo | 62 | 27.1 (4.2) | 21.4 (7.5) | -5.7 (6.3) | -5.7 (-7.2, -4.2) | ||
| Week 6 | |||||||
| Filorexant 10 mg | 58 | 26.5 (4.1) | 17.0 (8.7) | -9.5 (8.5) | -9.4 (-11.5, -7.4) | -0.3 (-3.2, 2.5) |
0.820 |
| Placebo | 61 | 27.2 (4.1) | 18.0 (8.0) | -9.1 (7.4) | -9.1 (-11.1, -7.1) | ||
| HAMD-17 total score | |||||||
| Week 3 | |||||||
| Filorexant 10 mg | 59 | 24.0 (5.3) | 17.5 (6.0) | -6.5 (6.3) | -6.6 (-8.1, -5.0) | -0.9 (-3.0, 1.3) |
0.412 |
| Placebo | 63 | 24.4 (4.9) | 18.7 (6.7) | -5.7 (6.1) | -5.7 (-7.2, -4.2) | ||
| Week 6 | |||||||
| Filorexant 10 mg | 56 | 23.9 (5.4) | 15.7 (7.5) | -8.2 (8.7) | -8.1 (-10.1, -6.2) | -0.5 (-3.2, 2.1) |
0.697 |
| Placebo | 61 | 24.4 (4.9) | 16.6 (7.0) | -7.8 (6.5) | -7.6 (-9.5, -5.7) | ||
| HAMD Bech subscale score | |||||||
| Week 3 | |||||||
| Filorexant 10 mg | 59 | 13.1 (2.3) | 9.3 (4.0) | -3.8 (3.5) | -3.8 (-4.8, -2.9) | -0.7 (-2.0, 0.5) |
0.250 |
| Placebo | 63 | 13.0 (2.1) | 9.9 (3.7) | -3.0 (3.6) | -3.1 (-4.0, -2.2) | ||
| Week 6 | |||||||
| Filorexant 10 mg | 56 | 13.1 (2.4) | 8.4 (4.9) | -4.7 (4.8) | -4.6 (-5.7, -3.4) | -0.3 (-1.9, 1.3) |
0.701 |
| Placebo | 61 | 13.0 (2.1) | 8.7 (4.0) | -4.2 (4.0) | -4.3 (-5.4, -3.2) | ||
Based on a constrained longitudinal data analysis model with terms for treatment, time, the interaction of time by treatment, severity of disease measured by the Hamilton Depression Rating Scale 17-item (HAMD-17) total score (≤20, >20) and insomnia severity index total score (ISI ≤14, >14).