Table 3 Secondary efficacy parameters, full analysis set
Time point, statistic | Placebo n = 196 | Armodafinil 150 mg/day n = 197 | P value |
|---|---|---|---|
LSM change from baseline in IDS-C30 total score | |||
Week 1 | −6.1 | −5.5 | 0.3025 |
Week 2 | −10.4 | −9.3 | 0.1940 |
Week 4 | −12.3 | −12.5 | 0.8481 |
Week 6 | −14.2 | −16.1 | 0.0926 |
Week 7* | −16.0 | −18.3 | 0.0492 |
Week 8 | −17.7 | −19.6 | 0.1174 |
Endpoint | −18.3 | −19.5 | 0.3526 |
LSM change from baseline in QIDS-C16 total score | |||
Week 1 | −2.6 | −2.4 | 0.3858 |
Week 2* | −4.5 | −3.8 | 0.0387 |
Week 4 | −5.2 | −5.2 | 0.9978 |
Week 6 | −6.0 | −6.5 | 0.3024 |
Week 7 | −6.7 | −7.4 | 0.1530 |
Week 8 | −7.4 | −7.7 | 0.5471 |
Endpoint | −7.0 | −7.1 | 0.7626 |
LSM change from baseline in CGI-S score | |||
Week 1 | −0.2 | −0.2 | 0.4497 |
Week 2 | −0.5 | −0.5 | 0.9625 |
Week 4 | −0.7 | −0.8 | 0.1467 |
Week 6* | −0.9 | −1.2 | 0.0226 |
Week 7 | −1.1 | −1.3 | 0.0757 |
Week 8* | −1.2 | −1.5 | 0.0159 |
Endpoint* | −1.1 | −1.3 | 0.0320 |
Proportion of CGI-S responders, n (%)a | |||
Week 1 | 4 (2) | 4 (2) | 0.9939 |
Week 2 | 15 (8) | 16 (8) | 0.8927 |
Week 4 | 28 (15) | 36 (20) | 0.2585 |
Week 6 | 44 (26) | 56 (33) | 0.1350 |
Week 7 | 55 (32) | 68 (40) | 0.1031 |
Week 8 | 66 (40) | 84 (50) | 0.0516 |
Endpoint | 67 (34) | 86 (44) | 0.0503 |
Week 4* | 5.3 | 7.7 | 0.0113 |
Week 8** | 11.4 | 15.2 | 0.0012 |
Endpoint** | 10.4 | 13.5 | 0.0066 |