Table 1.
Demographic and Clinical Characteristics of Patients at Baseline of Open-Label Study Versus Baseline of Acute Studies (Safety Populations)
| |
Acute study baseline |
Open-label study baseline |
|||
|---|---|---|---|---|---|
| Category | Schizophrenia population (n=222)a | Bipolar population (n=283)a | Combined population (n=380) | Schizophrenia subgroup (n=175) | Bipolar subgroup (n=205) |
| Demographic characteristics | |||||
| Age, years, mean (SD) | 15.4 (1.3) | 13.2 (2.2) | 14.4 (2.2) | 15.7 (1.4) | 13.3 (2.1) |
| Gender, n (%) | |||||
| Female | 91 (41.0) | 123 (43.5) | 154 (40.5) | 69 (39.4) | 85 (41.5) |
| Male | 129 (59.0) | 160 (56.5) | 226 (59.5) | 106 (60.6) | 120 (58.5) |
| Weight, (kg), mean (SD) | 61.7 (16.1) | 60.9 (18.3) | 62.1 (17.6) | 62.4 (16.0) | 61.8 (18.9) |
| BMI (kg/m2), mean (SD) | 22.3 (5.0) | 23.7 (5.2) | 23.3 (5.4) | 22.5 (5.5) | 24.1 (5.3) |
| Race, n (%) | |||||
| White | 137 (61.7) | 216 (76.3) | 268 (70.5) | 105 (60.0) | 163 (79.5) |
| Black | 27 (12.2) | 40 (14.1) | 45 (11.8) | 18 (10.3) | 27 (13.2) |
| Asian | 40 (18.0) | 1 (0.4) | 38 (10.0) | 38 (21.7) | 0 (0) |
| Other | 18 (8.1) | 26 (9.2) | 29 (7.6) | 14 (8.0) | 15 (7.3) |
| Clinical characteristics | Schizophrenia population (n=175)b | Bipolar population (n=205)b | Combined population (n=380) | Schizophrenia subgroup (n=175) | Bipolar subgroup (n=205) |
|---|---|---|---|---|---|
| CGAS score, mean (SD) | 42.7 (10.9) | 45.7(10.2) | 56.9 (14.7) | 54.7 (15.1) | 58.7 (14.1) |
| CGSQ score, mean (SD) | 5.7 (2.4) | 7.1 (2.3) | 5.5 (2.5) | 5.7 (2.4) | 5.2 (2.4) |
| PANSS total score, mean (SD) | 96.9 (16.8) | - | - | 73.1 (22.1) | - |
| CGI-S, mean (SD) | 4.6 (0.7) | - | 3.6 (1.2) | - | |
| YMRS total score, mean (SD) | - | 29.7 (5.9) | - | - | 16.3 (10.3) |
| CGI-BP-S, mean (SD) | - | 4.7 (0.7) | - | - | 3.1 (1.5) |
a
All patients in acute study safety populations.
b
Patients from acute studies who entered the open-label study
BMI, body mass index; CGAS, Children's Global Assessment Scale; CGSQ, Caregiver Strain Questionnaire; PANSS, Positive and Negative Syndrome Scale; CGI-S, Clinical Global Impressions – Severity; YMRS, Young Mania Rating Scale; CGI-BP-S, Clinical Global Impressions – Bipolar – Severity.