Table 2.
Secondary Endpoints (Full Analysis Set)
| Secondary endpoints | Placebo (n = 137) |
Seltorexant | ||
|---|---|---|---|---|
| 10 mg (n = 33) |
20 mg (n = 61) |
40 mg (n = 52) |
||
| Responsea at wk 6, n (%) | 39 (28.5%) | 8 (24.2%) | 25 (41.0%) | 20 (38.5%) |
| Remissionb at wk 6, n (%) | 26 (19.0%) | 5 (15.2%) | 18 (29.5%) | 14 (26.9%) |
| MADRS-6 | ||||
| LS mean difference (90% CI) | ||||
| Wk 3 | 0.4 (−1.91; 2.67) | −3.1 (−4.87; −1.41) | −0.8 (−2.59; 1.09) | |
| Wk 6 | 0.7 (−2.04; 3.54) | −1.8 (−3.93; 0.26) | −1.0 (−3.18; 1.27) | |
| MADRS-6 (baseline ISI ≥15) | ||||
| LS mean difference (90% CI) | ||||
| Week 3c | 0.6 (−4.50; 5.61) | −4.0 (−6.19; −1.75) | −0.6 (−2.80; 1.58) | |
| Week 6d | −0.4 (−6.73; 5.98) | −3.7 (−6.57; −0.89) | −1.1 (−3.92; 1.68) | |
| ISI total score at wk 6 | ||||
| LS mean difference (90% CI) | −0.5 (−2.63; 1.60) | −2.3 (−3.90; −0.67) | −1.9 (−3.64; −0.24) | |
| HAM-A total score at wk 6 | ||||
| LS mean difference (90% CI) | −1.9 (−4.42; 0.60) | −1.3 (−3.22; 0.56) | −1.1 (−3.10; 0.95) | |
| Patient-reported outcomes | ||||
| PHQ-9 at wk 6 | ||||
| LS mean difference (90% CI) | −0.5 (−2.56; 1.63) | −1.2 (−2.80; 0.36) | −0.0 (−1.73; 1.67) | |
| Remissione at wk 6 | 17 (12.4%) | 4 (12.1%) | 16 (26.2%) | 13 (25.0%) |
| Responsef at wk 6 | 56 (40.9%) | 12 (36.4%) | 30 (49.2%) | 22 (42.3%) |
| SHAPS | ||||
| LS mean difference (90% CI) | ||||
| Wk 3 | 0.4 (−0.89; 1.65) | −1.2 (−2.14; −0.22) | 0.3 (−0.70; 1.36) | |
| Wk 6 | 0.7 (−0.80; 2.12) | −0.7 (−1.84; 0.35) | 0.1 (−1.05; 1.30) | |
| PROMIS-SD T-score | ||||
| LS mean difference (90% CI) | ||||
| Wk 3 | −1.1 (−4.00; 1.84) | −4.3 (−6.49; −2.08) | −5.3 (−7.68; −2.96) | |
| Wk 6 | −1.0 (−4.17; 2.21) | −4.4 (−6.82; −2.04) | −5.3 (−7.83; −2.70) | |
| PROMIS-F T-score | ||||
| LS mean difference (90% CI) | ||||
| Wk 3 | −0.6 (−3.32; 2.19) | −2.9 (−4.98; −0.80) | −0.3 (−2.56; 1.92) | |
| Wk 6 | −0.8 (−4.16; 2.65) | −2.0 (−4.57; 0.58) | −1.0 (−3.78; 1.74) |
Abbreviations: HAM-A, Hamilton Anxiety Rating Scale; ISI, Insomnia Severity Index; LS, least squares; MADRS, Montgomery-Asberg Depression Rating Scale; PHQ, Patient Health Questionnaire; PROMIS-F, Patient Reported Outcome Measurement Information System- Fatigue; PROMIS-SD, Patient Reported Outcome Measurement Information System-Sleep Disturbance; SHAPS, Snaith-Hamilton Pleasure Scale.
a Defined as ≥50% improvement from baseline MADRS total score.
b Defined as MADRS total score ≤12.
c Placebo, n = 77; seltorexant 10 mg, n = 5; 20 mg, n = 35; 40 mg, n = 36.
d Placebo, n = 74; seltorexant 10 mg, n = 5; 20 mg, n = 32; 40 mg, n = 34.
e Defined as a PHQ-9 total score <5.
f Defined as ≥50% improvement in PHQ-9 total score from baseline.
Negative change in score indicates improvement.