Table 3.
Agreement in responsea and remissionb ratings for patient-rated IDS-SR30 compared with clinician-rated measures from baseline through acute-phase week 10; n (%) of patients.
| HAM-D17 |
CGI-S |
CGI-C |
||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Responder |
Remitter |
Responder |
Remitter |
Responder |
||||||||||||
| Week | IDS-SR30 | Yes | No | κ | Yes | No | κ | Yes | No | κ | Yes | No | κ | Yes | No | κ |
| Baselinec | Yes | 0 (0) | 0 (0) | - | 0 (0) | 2 (100) | −0.001 | - | - | - | 0 (0) | 2 (100) | −0.001 | - | - | - |
| No | 0 (0) | 1026 (100) | 1 (<1) | 1023 (>99) | 19 (2) | 1006 (98) | 1 (<1) | 1022 (>99) | - | - | - | |||||
| Week 1c | Yes | 22 (37) | 37 (63) | 0.33* | 8 (24) | 26 (76) | 0.23* | 32 (54) | 27 (46) | 0.20* | 7 (21) | 27 (79) | 0.21* | 28 (48) | 31 (52) | 0.28* |
| No | 37 (4) | 891 (96) | 22 (2) | 931 (98) | 148 (16) | 780 (84) | 19 (2) | 934 (98) | 81 (9) | 847 (91) | ||||||
| Week 2 | Yes | 88 (64) | 49 (36) | 0.47* | 34 (49) | 35 (51) | 0.48* | 114 (84) | 22 (16) | 0.29* | 36 (53) | 32 (47) | 0.41* | 97 (71) | 40 (29) | 0.39* |
| No | 90 (11) | 711 (89) | 29 (3) | 840 (97) | 269 (34) | 531 (66) | 54 (6) | 814 (94) | 149 (19) | 650 (81) | ||||||
| Week 3c | Yes | 180 (74) | 62 (26) | 0.50* | 63 (53) | 56 (47) | 0.46* | 218 (90) | 24 (10) | 0.31* | 79 (66) | 40 (34) | 0.43* | 186 (77) | 56 (23) | 0.38* |
| No | 132 (20) | 536 (80) | 57 (7) | 734 (93) | 317 (48) | 350 (52) | 107 (14) | 683 (86) | 206 (31) | 461 (69) | ||||||
| Week 4 | Yes | 272 (80) | 66 (20) | 0.51* | 130 (64) | 74 (36) | 0.51* | 314 (93) | 23 (7) | 0.30* | 146 (72) | 57 (28) | 0.46* | 299 (89) | 38 (11) | 0.43* |
| No | 154 (26) | 430 (74) | 85 (12) | 633 (88) | 336 (58) | 248 (42) | 139 (19) | 579 (81) | 238 (41) | 345 (59) | ||||||
| Week 6 | Yes | 367 (89) | 45 (11) | 0.51* | 213 (78) | 60 (22) | 0.57* | 405 (98) | 6 (2) | 0.30* | 235 (86) | 37 (14) | 0.49* | 389 (95) | 22 (5) | 0.39* |
| No | 175 (37) | 297 (63) | 110 (18) | 501 (82) | 318 (68) | 151 (32) | 182 (30) | 426 (70) | 256 (55) | 213 (45) | ||||||
| Week 8 | Yes | 416 (92) | 38 (8) | 0.46* | 256 (81) | 59 (19) | 0.56* | 447 (99) | 4 (1) | 0.27* | 267 (86) | 45 (14) | 0.44* | 428 (95) | 23 (5) | 0.34* |
| No | 165 (47) | 183 (53) | 113 (23) | 374 (77) | 256 (74) | 88 (26) | 186 (38) | 297 (62) | 219 (64) | 125 (36) | ||||||
| Week 10 | Yes | 499 (95) | 25 (5) | 0.34* | 330 (86) | 55 (14) | 0.52* | 510 (98) | 11 (2) | 0.20* | 353 (92) | 29 (8) | 0.42* | 494 (95) | 27 (5) | 0.26* |
| No | 172 (66) | 88 (34) | 134 (34) | 265 (66) | 212 (82) | 47 (18) | 199 (50) | 199 (50) | 189 (73) | 70 (27) | ||||||
CGI-C, Clinical Global Impressions—Change; CGI-S, Clinical Global Impressions—Severity; HAM-D17, 17-item Hamilton Rating Scale for Depression; IDS-SR30, 30-item Inventory of Depressive Symptomatology—Self-Report; κ kappa statistic.
Response: CGI-S score≤3, CGI-C score≤2, and ≥50% reduction from baseline on HAM-D17 total score, IDS-SR30 total score.
Remission: CGI-S score≤2, HAM-D17 total score≤7, IDS-SR30 total score≤14, and QIDS-SR16 total score≤5.
IDS-SR30 values missing for ≥1.0% of patients: baseline, 21/1047 (2.0%); week 1, 11/999 (1.1%); week 3,12/923 (1.3%).
P<0.0001.