Table 1.
Baseline demographics and clinical characteristics in two studies of paliperidone ER for schizoaffective disorder (intent-to-treat analysis set)
| Parameter | Paliperidone ER (n = 414) | Placebo (n = 200) | Overall (n = 614) |
|---|---|---|---|
| Age, y, mean (SD) | 37.5 (9.7) | 37.2 (10.3) | 37.4 (9.9) |
| Sex, n (%) | |||
| Male | 250 (60.4) | 121 (60.5) | 371 (60.4) |
| Female | 164 (39.6) | 79 (39.5) | 243 (39.6) |
| Race, n (%) | |||
| Caucasian | 200 (48.3) | 100 (50.0) | 300 (48.9) |
| African American | 81 (19.6) | 37 (18.5) | 118 (19.2) |
| Asian | 129 (31.2) | 63 (31.5) | 192 (31.3) |
| Other | 4 (1.0) | 0 (0) | 4 (1.0) |
| BMI, kg/m2, mean (SD) | 27.2 (7.3) | 27.9 (7.6) | 27.5 (7.4) |
| Baseline mood stabilizers or antidepressants, n (%) | 186 (44.9) | 89 (44.5) | 275 (44.8) |
| Age at first psychiatric diagnosis, y, mean (SD) | 25.1 (8.9) | 25.4 (10.1) | 25.2 (9.3) |
| n = 408 | n = 195 | n = 603 | |
| Age at first SCA diagnosis, y, mean (SD) | 31.5 (10.1) | 32.0 (10.4) | 31.7 (10.2) |
| Prior diagnoses, n (%)a | |||
| Schizophrenia | 194 (46.9) | 96 (48.0) | 290 (47.2) |
| Bipolar disorder | 119 (28.7) | 71 (35.5) | 190 (30.9) |
| Depression | 72 (17.4) | 40 (20.0) | 112 (18.2) |
| SCA diagnosis prior to screening, n (%) | n = 408 | n = 195 | n = 603 |
| 366 (89.7) | 182 (93.3) | 548 (90.9) | |
| SCA disorder type, n (%) | n = 411 | n = 200 | n = 611 |
| Bipolar | 288 (70.0) | 133 (67.0) | 421 (68.9) |
| Depressive | 123 (30.0) | 67 (34.0) | 190 (31.1) |
| n = 409 | n = 196 | n = 605 | |
| Total psychiatric hospitalizations, mean (SD) | 6.2 (7.6) | 6.6 (9.9) | 6.3 (8.4) |
| n = 413 | n = 199 | n = 612 | |
| Suicide attempts, n (%) | 128 (31.0) | 64 (32.2) | 192 (31.4) |
| 1 | 68 (53.1) | 32 (50.0) | 100 (52.1) |
| ≥2 | 60 (46.9) | 32 (50.0) | 92 (47.9) |
| Current tobacco use, yes, n (%) | 240 (58.0) | 115 (57.5) | 355 (57.8) |
| History of alcohol/drug use, yes, n (%) | 124 (30.0) | 59 (29.5) | 183 (29.8) |
| Alcohol | 79 (63.7) | 42 (71.2) | 121 (66.1) |
| Cocaine | 56 (45.2) | 30 (50.9) | 86 (47.0) |
| Marijuana | 63 (50.8) | 25 (42.4) | 88 (48.1) |
| Otherb | 26 (21.0) | 10 (17.0) | 36 (19.7) |
| PANSS score, mean (SD) | |||
| Total | 93.3 (13.2) | 91.6 (12.3) | 92.8 (13.0) |
| Positive symptoms | 27.4 (5.3) | 27.1 (5.0) | 27.3 (5.2) |
| Negative symptoms | 18.8 (6.2) | 18.2 (5.9) | 18.6 (6.1) |
| Anxiety/depression | 13.2 (3.7) | 12.9 (3.9) | 13.1 (3.7) |
| Disorganized thoughts | 19.7 (4.2) | 19.3 (4.0) | 19.6 (4.1) |
| Hostility/uncontrolled excitement | 14.2 (3.0) | 14.1 (3.1) | 14.2 (3.0) |
| CGI-S-SCA, mean (SD) | |||
| Total score | 4.6 (0.6) | 4.6 (0.6) | 4.6 (0.6) |
| Positive domain | 4.5 (0.7) | 4.5 (0.7) | 4.5 (0.7) |
| Negative domain | 3.3 (1.1) | 3.2 (1.1) | 3.2 (1.1) |
| Depressive domain | 3.2 (1.5) | 3.2 (1.5) | 3.2 (1.5) |
| Manic domain | 3.5 (1.5) | 3.5 (1.6) | 3.5 (1.5) |
| YMRS, mean (SD) | 24.6 (10.1) | 24.2 (10.1) | 24.4 (10.0) |
| HAM-D-21, mean (SD) | 20.4 (9.0) | 19.6 (8.3) | 20.1 (8.8) |
| YMRS ≥ 16, n (%) | 328 (79.2) | 160 (80.0) | 488 (79.5) |
| HAM-D-21 ≥ 16, n (%) | 282 (68.1) | 129 (64.5) | 411 (66.9) |
| YMRS and HAM-D-21 ≥ 16, n (%) | 196 (47.3) | 89 (44.5) | 285 (46.4) |
a
Notes: Data are not mutually exclusive;
b
Other includes heroin, depressants, mixed substance use, and other compounds.
Abbreviations: BMI, body mass index; CGI-S-SCA, Clinical Global Impressions of Severity for Schizoaffective Disorder; ER, extended-release; HAM-D-21, 21-item Hamilton Rating Scale for Depression; PANSS, Positive and Negative Syndrome Scale; SCA, schizoaffective disorder; SD, standard deviation; YMRS, Young Mania Rating Scale; y, years.