Table 1 Baseline demographic and clinical characteristics, disposition, and RLAI mean daily dose and dose distribution (ITT analysis set)
Total (N = 162) | Baseline Depressive Symptoms (n = 59) | Baseline Manic or Mixed Symptoms (n = 103) | |
|---|---|---|---|
Baseline demographic and clinical characteristics | |||
Age, years | |||
Mean (SD) | 38.6 (11.4) | 41.0 (11.5) | 37.2 (11.2) |
Median (range) | 39 (18-70) | 41 (22-70) | 38 (18-61) |
Gender, n (%) | |||
Male | 92 (56.8) | 28 (47.5) | 64 (62.1) |
Female | 70 (43.2) | 31 (52.5) | 39 (37.9) |
Race, n (%) | |||
Caucasian | 51 (31.5) | 19 (32.2) | 32 (31.1) |
Hispanic | 3 (1.9) | 2 (3.4) | 1 (1.0) |
Black | 18 (11.1) | 5 (8.5) | 13 (12.6) |
Other (Indian) | 90 (55.6) | 33 (55.9) | 57 (55.3) |
Bipolar disorder subtype, n(%) | |||
Type I | 144 (88.9) | 48 (81.4) | 96 (93.2) |
Type II | 18 (11.1) | 11 (18.6) | 7 (6.8) |
Most recent episode, n (%) | |||
Depressed | 56 (34.6) | 44 (74.6) | 12 (11.7) |
Manic | 79 (48.8) | 6 (10.2) | 73 (70.9) |
Mixed | 19 (11.7) | 8 (13.6) | 11 (10.7) |
Hypomanic | 8 (4.9) | 1 (1.7) | 7 (6.8) |
Time since most recent episode, weeks, mean (SD) | 6.0 (4.6) | 6.1 (4.8) | 5.9 (4.5) |
Disposition | |||
Completed OL phase | 120 (74.1) | 44 (74.6) | 76 (73.8) |
Discontinued | 42 (25.9) | 15 (25.4) | 27 (26.2) |
Reason for discontinuation | |||
Withdrawal of consent | 14 (8.6) | 7 (11.9) | 7 (6.8) |
AEs | 13 (8.0) | 6 (10.2) | 7 (6.8) |
Lost to follow-up | 10 (6.2) | 2 (3.4) | 8 (7.8) |
Nonadherent | 1 (0.6) | 0 (0) | 1 (1.0) |
Other | 4 (2.5)a | 0 (0) | 4 (3.9)a |
RLAI mean daily dose and dose distribution | |||
Dose, mg, mean (SD) | 27.9 (5.6) | 26.5 (4.1) | 28.6 (6.2) |
Dose distribution, n (%) | |||
25 mg | 127 (78.4) | 52 (88.1) | 75 (72.8) |
37.5 mg | 33 (20.4) | 7 (11.9) | 26 (25.2) |
50 mg | 2 (1.2) | 0 (0) | 2 (1.9) |