Table 1.
Baseline demographic and clinical characteristics
| Asenapine (n = 372) | Placebo (n = 197) | Olanzapine (n = 391) | Total (N = 960) | |
|---|---|---|---|---|
| Male, n (%) | 203 (54.6) | 98 (49.7) | 230 (58.8) | 531 (55.3) |
| Age (years), median (range) | 40 (18–76) | 39 (18–69) | 39 (18–67) | 39 (18–76) |
| Unemployed, n (%) | 270 (72.6) | 139 (70.6) | 285 (72.9) | 694 (72.3) |
| DSM-IV BD-I diagnosis, n (%) | ||||
| Manic episode | 265 (71.2) | 131 (66.5) | 269 (68.8) | 665 (69.3) |
| Mixed episode | 107 (28.8) | 66 (33.5) | 122 (31.2) | 295 (30.7) |
| YMRS total scorea, mean (SD) | 28.8 (6.2) | 28.7 (6.2) | 29.2 (6.3) | 28.9 (6.2) |
| MADRS total scorea, mean (SD) | 10.8 (7.0) | 12.4 (7.8) | 11.3 (7.3) | 11.3 (7.3) |
| CGI-BP mania severity scorea, mean (SD) | 4.7 (0.8) | 4.6 (0.8) | 4.6 (0.8) | 4.6 (0.8) |
| CGI-BP depression severity scorea, mean (SD) | 2.0 (1.2) | 2.2 (1.3) | 2.1 (1.3) | 2.1 (1.3) |
| Number of depressive symptomsb, n (%) | ||||
| 0–2 | 201 (54.0) | 100 (50.8) | 205 (52.4) | 506 (52.7) |
| 3 or more | 171 (46.0) | 97 (49.2) | 186 (47.6) | 454 (47.3) |
| Severity of depressive symptoms, n (%) | ||||
| MADRS Total score <20 | 328 (88.2) | 164 (83.2) | 338 (86.4) | 830 (86.5) |
| MADRS Total score ≥20 | 44 (11.8) | 33 (16.8) | 53 (13.6) | 130 (13.5) |
| Anxietyc, n (%) | ||||
| Absent or minimal | 144 (38.7) | 73 (37.1) | 150 (38.4) | 367 (38.2) |
| Present | 227 (61.0) | 124 (62.9) | 238 (60.9) | 589 (61.4) |
| Not rated | 1 (0.3) | 0 (0.0) | 3 (0.8) | 4 (0.4) |
| Irritabilityd, n (%) | ||||
| Absent or low | 150 (40.3) | 65 (33.0) | 134 (34.3) | 349 (36.4) |
| Present | 218 (58.6) | 128 (65.0) | 253 (64.7) | 599 (62.4) |
| Not rated | 4 (1.1) | 4 (2.0) | 4 (1.0) | 12 (1.3) |
| Agitatione, n (%) | ||||
| Absent or low | 83 (22.3) | 48 (24.4) | 84 (21.5) | 215 (22.4) |
| Present | 285 (76.6) | 145 (73.6) | 303 (77.5) | 733 (76.4) |
| Not rated | 4 (1.1) | 4 (2.0) | 4 (1.0) | 12 (1.3) |
| Severe AIAf, n (%) | ||||
| Not present | 247 (66.4) | 123 (62.4) | 248 (63.4) | 618 (64.4) |
| Present | 120 (32.3) | 70 (35.5) | 136 (34.8) | 326 (34.0) |
| One or more symptom not rated | 5 (1.3) | 4 (2.0) | 7 (1.8) | 16 (1.7) |
AIA, anxiety, irritability, and agitation; BD-I, bipolar I disorder; CGI-BP, Clinical Global Impressions-Bipolar version; DSM-IV, Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition; MADRS, Montgomery–Åsberg Depression Rating Scale; PANSS, Positive and Negative Syndrome Scale; SD, standard deviation; YMRS, Young Mania Rating Scale
aFor patients missing a value at baseline, the value was used from the screening visit
bBased on the number of individual MADRS items with a score of ≥1
cBased on the PANSS anxiety item: ‘absent or minimal’ indicates a score of ≤2; ‘present’ indicates a score of ≥3
dBased on the YMRS irritability item: ‘absent or low’ indicates a score of ≤3; ‘present’ indicates a score of ≥4
eBased on the YMRS increased motor activity–energy item: ‘absent or low’ indicates a score of ≤2; ‘present’ indicates a score of ≥3
fMeeting the above criteria for all three AIA symptoms