Table 1 Baseline Characteristics and Stratification Factors
Parameter | Result | Saline (N = 5) | Ketamine (N = 17) | ketamine | saline | All Patients (N = 22) | ||
|---|---|---|---|---|---|---|---|---|
DCS plus lurasidone (N = 12) | lurasidone (N = 5) | DCS plus lurasidone (N = 4) | lurasidone (N = 1) | |||||
Age | Mean | 43.6 | 38.4 | 33.9 | 49.0 | 41.0 | 54.0 | 39.5 |
Median | 46.0 | 42.0 | 30.0 | 45.0 | 42.0 | 54.0 | 42.5 | |
Std Dev | 9.63 | 11.90 | 10.47 | 8.03 | 8.87 | 0 | 11.43 | |
Min, Max | 30, 54 | 19, 60 | 19, 48 | 42, 60 | 30, 50 | 54, 54 | 19, 60 | |
95% CI | (31.6, 55.6) | (32.2, 44.5) | (27.3, 40.6) | (39.0, 59.0) | (26.9, 55.1) | 0 | (34.5, 44.6) | |
Sex [n (%)] | Male | 3 (60.0) | 13 (76.5) | 9 (75.0) | 4 (80.0) | 2 (50.0) | 1 (100) | 16 (72.7) |
Female | 2 (40.0) | 4 (23.5) | 3 (25.0) | 1 (20.0) | 2 (50.0) | 0 | 6 (27.3) | |
Race [n (%)] | White | 3 (60.0) | 16 (94.1) | 11 (91.7) | 5 (100) | 3 (75.0) | 0 | 19 (86.4) |
Black or African-American | 2 (40.0) | 1 (5.9) | 1 (8.3) | 0 | 1 (25.0) | 1 (100) | 3 (13.6) | |
Ethnicity [n (%)] | Hispanic | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Non-Hispanic | 5 (100) | 17 (100) | 12 (100) | 5 (100) | 4 (100) | 1 (100) | 22 (100) | |
Baseline C-SSRS | 1 | 0 | 1 (5.9) | 1 (8.3) | 0 | 0 | 0 | 1 (4.5) |
Score [n (%)]* | 4 | 0 | 2 (11.8) | 2 (16.7) | 0 | 0 | 0 | 2 (9.1) |
5 | 5 (100) | 14 8 (2.4) | 9 (75.0) | 5 (100) | 4 (100) | 1 (100) | 19 (86.4) | |
Hypomanic | None | 4 (80.0) | 13 (76.5) | 9 (75.0) | 4 (80.0) | 3 (75.0) | 1 (100) | 17 (77.3) |
symptoms (BISS) | Any | 1 (20.0) | 4 (23.5) | 3 (25.0) | 1 (20.0) | 1 (25.0) | 0 | 5 (22.7) |
Suicidal Event in | None | 1 (20.0) | 3 (17.6) | 3 (25.0) | 0 | 1 (25.0) | 0 | 4 (18.2) |
Prior 12 Months | Any | 4 (80.0) | 14 (82.4) | 9 (75.0) | 5 (100) | 3 (75.0) | 1 (100) | 18 (81.8) |