Table 3.
Remission or response in continuation phase by week 10 clinician-patient assessment discrepancy.
| Visit | Patient Category at Week 10 | Remission |
Response |
||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| HAM-D17 | CGI-S | IDS-SR | HAM-D17 | CGI-C | IDS-SR | ||||||||
| Yes |
No |
Yes |
No |
Yes |
No |
Yes |
No |
Yes |
No |
Yes |
No |
||
| n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | n (%) | ||
| Month 6 | Concordant | 275 (83) | 56† (17) | 299 (91) | 31† (9) | 234 (71) | 97† (29) | 314 (95) | 17 (5) | 299 (91) | 31† (9) | 277 (84) | 54‡ (16) |
| Nonconcordant | 71 (68) | 33 (32) | 82 (79) | 22 (21) | 59 (57) | 45 (43) | 97 (93) | 7 (7) | 82 (79) | 22 (21) | 71 (68) | 33 (32) | |
| Final Visit | Concordant | 379 (76) | 123‡ (24) | 415 (83) | 87‡ (17) | 321 (64) | 180† (36) | 451 (90) | 51* (10) | 415 (83) | 87† (17) | 389 (78) | 112‡ (22) |
| Nonconcordant | 104 (59) | 72 (41) | 124 (70) | 52 (30) | 88 (50) | 87 (50) | 146 (83) | 30 (17) | 124 (70) | 52 (30) | 107 (61) | 68 (39) | |
CGI-S = Clinical Global Impression—Severity; HAM-D17= 17-item Hamilton Rating Scale for Depression; IDS-SR = Inventory of Depressive Symptomatology–Self-Report; ITT = intent to treat.
Remission is defined as: HAM-D17≤ 7; CGI-S ≤2; IDS-SR ≤ 14.
Response is defined as: HAM-D17 decrease ≥50% from acute phase baseline; CGI-C ≤ 2; IDS-SR decrease ≥50% or more from acute phase baseline.
*
P≤ 0.05 from Mantel-Haenszel chi-square test concordance-rater vs nonconcordance.
†
P≤ 0.01 from Mantel-Haenszel chi-square test concordance-rater vs nonconcordance.
‡
P< 0.001 from Mantel-Haenszel chi-square test concordance-rater vs nonconcordance.