Table 1.
Baseline Demographic and Psychiatric Characteristics of Randomized Patients by Early Response Statusa
| Phase C Early Responders (n = 157) |
Phase C Early Nonresponders (n = 907) |
|||
| Characteristic | Placebo (n = 47) | Aripiprazole (n = 110) | Placebo (n = 478) | Aripiprazole (n = 429) |
| Demographics | ||||
| Age, mean (SD), y | 44.7 (10.7) | 46.2 (10.2) | 44.9 (10.9) | 45.3 (10.9) |
| Sex, n (%), male | 10 (21.3) | 19 (17.3) | 163 (34.1) | 151 (35.2) |
| Weight, mean (SD), kg | 86.0 (24.9) | 83.1 (21.7) | 87.9 (22.0) | 85.9 (20.1) |
| Body mass index, mean (SD), kg/m2 | 31.2 (9.2) | 30.1 (7.4) | 30.9 (7.5) | 30.3 (7.1) |
| Race, n (%) | ||||
| White | 41 (87.2) | 98 (89.1) | 429 (89.7) | 378 (88.1) |
| Black | 5 (10.6) | 11 (10.0) | 36 (7.5) | 30 (7.0) |
| Other | 1 (2.1) | 1 (0.9) | 13 (2.7) | 21 (4.9) |
| Ethnicity, n (%) | ||||
| Not Hispanic/Latino | 45 (95.7) | 102 (92.7) | 440 (92.1) | 412 (96.3) |
| Psychiatric characteristics | ||||
| Duration of current episode, median (SD), mo | 14.7 (35.9) | 22.8 (66.2) | 19.6 (67.5) | 17.8 (65.0) |
| Age of first depressive episode, mean (SD), y | 28.3 (13.7) | 26.7 (12.0) | 27.2 (13.4) | 27.4 (13.3) |
| No. of depressive episodes, mean (SD) | 4.4 (4.0) | 4.4 (3.5) | 6.0 (11.6) | 5.5 (9.8) |
| Antidepressant therapy, n (%) | ||||
| Escitalopram | 14 (29.8) | 31 (28.2) | 137 (28.7) | 143 (33.3) |
| Fluoxetine | 5 (10.6) | 14 (12.7) | 71 (14.9) | 70 (16.3) |
| Paroxetine controlled release | 6 (12.8) | 9 (8.2) | 41 (8.6) | 34 (7.9) |
| Sertraline | 14 (29.8) | 18 (16.4) | 90 (18.8) | 71 (16.6) |
| Venlafaxine extended release | 8 (17.0) | 38 (34.5) | 139 (29.1) | 111 (25.9) |
| Previous antidepressant therapy trials to current episode, n (%) | ||||
| 0 | … | … | 5 (1.0) | 3 (0.7) |
| 1 | 35 (74.5) | 74 (67.3) | 316 (66.2) | 299 (69.9) |
| 2 | 11 (23.4) | 29 (26.4) | 129 (27.0) | 102 (23.8) |
| ≥ 3 | 1 (2.1) | 7 (6.4) | 27 (5.7) | 24 (5.6) |
a
Early response was defined as a ≥ 50% reduction in Montgomery-Asberg Depression Rating Scale total score at week 2.