Table 1.
Patient demographics and baseline characteristics (ITT cohort)
| Characteristics, mean (SD) | Overall N = 251 | Aripiprazole group n = 82 | Blonanserin group n = 85 | Paliperidone group n = 84 | Statistical test (P value) |
|---|---|---|---|---|---|
| Age, years | 46.5 (13.3) | 48.0 (14.1) | 46.7 (12.6) | 45.0 (13.2) | 0.3626 a |
| Sex, male, n (%) | 133 (53.0) | 42 (51.2) | 48 (56.5) | 43 (51.2) | 0.7313 b |
| Height, cm | 162.9 (9.0) | 161.5 (9.6) | 163.7 (9.0) | 163.4 (8.1) | 0.2212 a |
| Body weight, kg | 67.7 (14.9) | 66.5 (17.4) | 69.1 (14.5) | 67.3 (12.5) | 0.5174 a |
| Disease type (DSM‐IV classifications), n (%) | |||||
| Paranoid | 161 (64.1) | 55 (67.1) | 51 (60.0) | 55 (65.5) | 0.5029 b |
| 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) | 0.2392 a |
| <6, n (%) | 57 (22.7) | 19 (23.2) | 18 (21.2) | 20 (23.8) | 0.9132 b |
| ≥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) | 0.7986 b |
| 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) | 0.4430 b |
| 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) | 0.0404 b |
| 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) | 0.9347 a |
| <1000 mg | 221 (93.6) | 71 (92.2) | 76 (93.8) | 74 (94.9) | 0.7910 b |
| ≥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) | 0.9722 b |
| ≥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) | 0.0548 b |
| Hypertension | 29 (11.6) | 13 (15.9) | 9 (10.6) | 7 (8.3) | 0.2991 b |
| Diabetes | 24 (9.6) | 9 (11.0) | 8 (9.4) | 7 (8.3) | 0.8444 b |
| Hyperlipidemia | 38 (15.1) | 14 (17.1) | 13 (15.3) | 11 (13.1) | 0.7736 b |
| Others | 142 (56.6) | 55 (67.1) | 45 (52.9) | 42 (50.0) | 0.0604 b |
| Social functioning (PSP) total score | 56.3 (20.8) | 59.0 (21.0) | 53.6 (21.1) | 56.5 (20.4) | 0.2487 a |
| Social functioning (EQ‐5D utility value) | 0.788 (0.167) c | 0.779 (0.168) | 0.768 (0.176) | 0.818 (0.153) d | 0.1258 a |
| PANSS total score | 73.8 (21.1) | 75.2 (22.2) | 75.7 (18.4) | 70.5 (22.4) | 0.2094 a |
| DIEPSS overall severity, n (%) | |||||
| None, normal | 163 (64.9) | 44 (53.7) | 60 (70.6) | 59 (70.2) | 0.0199 e |
| 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 | 224 (89.2) | 75 (91.5) | 76 (89.4) | 73 (86.9) | 0.6370 b |
| Days elapsed until switch to monotherapy f | 20.0 (19.0) g | 20.4 (19.5) h | 20.5 (20.5) i | 19.2 (17.2) j | 0.8962 a |
| Days elapsed until switch to monotherapy among patients with prior medication | 21.3 (19.0) k | 21.5 (19.5) l | 21.3 (20.5) j | 20.9 (16.9) m | 0.9795 a |
a
ANOVA.
b
χ2 test.
c
n = 250.
d
n = 83.
e
Kruskal‐Wallis test.
f
Elapsed days for patients without prior medication was defined as zero.
g
n = 224.
h
n = 75.
i
n = 76.
j
n = 73.
k
n = 210.
l
n = 70.
m
n = 67.
ANOVA, analysis of variance; DIEPSS, Drug‐Induced Extrapyramidal Symptoms Scale; DSM, Diagnostic and Statistical Manual of Mental Disorders; EQ‐5D, EuroQol‐5 dimensions; ITT, intent to treat; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance Scale; SD, standard deviation.