Table 1.
Patient demographics and baseline characteristics (ITT cohort)
| Characteristic, mean (SD) | Overall N = 251 |
Aripiprazole group n = 82 |
Blonanserin group n = 85 |
Paliperidone group n = 84 |
|---|---|---|---|---|
| Age, years | 46.5 (13.3) | 48.0 (14.1) | 46.7 (12.6) | 45.0 (13.2) |
| Sex, male, n (%) | 133 (53.0) | 42 (51.2) | 48 (56.5) | 43 (51.2) |
| Height, cm | 162.9 (9.0) | 161.5 (9.6) | 163.7 (9.0) | 163.4 (8.1) |
| Body weight, kg | 67.7 (14.9) | 66.5 (17.4) | 69.1 (14.5) | 67.3 (12.5) |
| Disease type (DSM-IV classifications), n (%) | ||||
| Paranoid | 161 (64.1) | 55 (67.1) | 51 (60.0) | 55 (65.5) |
| Disorganized | 15 (6.0) | 3 (3.7) | 6 (7.1) | 6 (7.1) |
| Catatonic | 9 (3.6) | 5 (6.1) | 2 (2.4) | 2 (2.4) |
| Undifferentiated | 22 (8.8) | 5 (6.1) | 7 (8.2) | 10 (11.9) |
| Residual | 44 (17.5) | 14 (17.1) | 19 (22.4) | 11 (13.1) |
| Clinical picture (selected parameters), n (%) | ||||
| Hallucinatory/delusion state | 76 (30.3) | 28 (34.1) | 25 (29.4) | 23 (27.4) |
| Delusions in foreground | 27 (10.8) | 10 (12.2) | 9 (10.6) | 8 (9.5) |
| Loss of initiative/apathy in foreground I | 14 (5.6) | 4 (4.9) | 4 (4.7) | 6 (7.1) |
| Loss of initiative/apathy in foreground II | 123 (49.0) | 42 (51.2) | 44 (51.8) | 37 (44.0) |
| Neurosis-like state in foreground | 16 (6.4) | 3 (3.7) | 4 (4.7) | 9 (10.7) |
| Disease duration, years | 17.1 (12.3) | 18.9 (13.3) | 16.5 (11.7) | 15.8 (11.9) |
| < 6, n (%) | 57 (22.7) | 19 (23.2) | 18 (21.2) | 20 (23.8) |
| ≥ 6, n (%) | 194 (77.3) | 63 (76.8) | 67 (78.8) | 64 (76.2) |
| Prior treatment, n (%) | ||||
| No | 15 (6.0) | 5 (6.1) | 4 (4.7) | 6 (7.1) |
| Yes | 236 (94.0) | 77 (93.9) | 81 (95.3) | 78 (92.9) |
| Reason for switching from prior medications, n (%) | ||||
| Lack of efficacy of prior medications | 99 (41.9) | 32 (41.6) | 34 (42.0) | 33 (42.3) |
| Treated with polypharmacy | 23 (9.7) | 8 (10.4) | 10 (12.3) | 5 (6.4) |
| Lowered tolerability | 54 (22.9) | 19 (24.7) | 13 (16.0) | 22 (28.2) |
| Patient’s reason | 30 (12.7) | 7 (9.1) | 11 (13.6) | 12 (15.4) |
| Others | 30 (12.7) | 11 (14.3) | 13 (16.0) | 6 (7.7) |
| Monotherapy/polypharmacy, n (%) | ||||
| Monotherapy (1) | 182 (77.1) | 53 (68.8) | 62 (76.5) | 67 (85.9) |
| Polypharmacy (≥ 2) | 54 (22.9) | 24 (31.2) | 19 (23.5) | 11 (14.1) |
| Chlorpromazine-equivalent dose, mean (SD) and n (%) | ||||
| Mean (SD) | 442.5 (321.7) | 453.6 (335.1) | 436.4 (304.0) | 438.0 (329.8) |
| < 1000 mg | 221 (93.6) | 71 (92.2) | 76 (93.8) | 74 (94.9) |
| ≥ 1000 mg | 15 (6.4) | 6 (7.8) | 5 (6.2) | 4 (5.1) |
| < 400 mg | 116 (49.2) | 38 (49.4) | 39 (48.1) | 39 (50.0) |
| ≥ 400 mg | 120 (50.8) | 39 (50.6) | 42 (51.9) | 39 (50.0) |
| Comorbidities, n (%) | 167 (66.5) | 63 (76.8) | 52 (61.2) | 52 (61.9) |
| Hypertension | 29 (11.6) | 13 (15.9) | 9 (10.6) | 7 (8.3) |
| Diabetes | 24 (9.6) | 9 (11.0) | 8 (9.4) | 7 (8.3) |
| Hyperlipidemia | 38 (15.1) | 14 (17.1) | 13 (15.3) | 11 (13.1) |
| Others | 142 (56.6) | 55 (67.1) | 45 (52.9) | 42 (50.0) |
| Social functioning (PSP) total score | 56.3 (20.8) | 59.0 (21.0) | 53.6 (21.1) | 56.5 (20.4) |
| Social functioning (EQ-5D utility value) | 0.788 (0.167)a | 0.779 (0.168) | 0.768 (0.176) | 0.818 (0.153)b |
| PANSS total score | 73.8 (21.1) | 75.2 (22.2) | 75.7 (18.4) | 70.5 (22.4) |
| DIEPSS overall severity, n (%) | ||||
| None, normal | 163 (64.9) | 44 (53.7) | 60 (70.6) | 59 (70.2) |
| Minimal, questionable | 60 (23.9) | 24 (29.3) | 17 (20.0) | 19 (22.6) |
| Mild | 20 (8.0) | 8 (9.8) | 7 (8.2) | 5 (6.0) |
| Moderate | 7 (2.8) | 5 (6.1) | 1 (1.2) | 1 (1.2) |
| Severe | 1 (0.4) | 1 (1.2) | 0 (0.0) | 0 (0.0) |
| Per-protocol switch to monotherapy within 8 weeks from randomization, n (%) | 224 (89.2) | 75 (91.5) | 76 (89.4) | 73 (86.9) |
| Days elapsed until switch to monotherapyc | 20.0 (19.0)d | 20.4 (19.5)e | 20.5 (20.5)f | 19.2 (17.2)g |
| Days elapsed until switch to monotherapy among patients with prior medication | 21.3 (19.0)h | 21.5 (19.5)i | 21.3 (20.5)g | 20.9 (16.9)j |
DIEPSS Drug-Induced Extrapyramidal Symptoms Scale, DSM Diagnostic and Statistical Manual of Mental Disorders, EQ-5D EuroQol-5 dimension, ITT intent-to-treat, PANSS Positive and Negative Syndrome Scale, PSP Personal and Social Performance Scale, SD standard deviation
an = 250; bn = 83; celapsed days for patients without prior medication were defined as zero; dn = 224; en = 75; fn = 76; gn = 73; hn = 210; in = 70; jn = 67