Table 1.
Patient Demographics and Clinical Characteristics at Baseline (ITT Population)
| Total (N=287) | Modal 40 mg Group (n=151) | Modal 80 mg Group (n=136) | |
|---|---|---|---|
| Sex (Male) [n (%)] | 143 (49.8) | 78 (51.7) | 65 (47.8) |
| Age (Years) [mean (SD)] | 40.1 (11.26) | 41.2 (11.44) | 38.8 (10.96) |
| Double-blind baseline score [mean (SD)] | |||
| PANSS total | 101.1 (11.00) | 100.2 (10.51) | 102.1 (11.47) |
| Positive subscale | 25.3 (3.80) | 25.0 (3.66) | 25.8 (3.93) |
| Negative subscale | 24.2 (4.08) | 24.0 (3.84) | 24.5 (4.33) |
| General Psychopathology Subscale | 51.5 (6.41) | 51.2 (6.22) | 51.8 (6.62) |
| CGI-S | 4.9 (0.60) | 4.8 (0.59) | 5.0 (0.60) |
| CDSS | 4.1 (3.73) (n=286) | 3.9 (3.58) (n=150) | 4.4 (3.88) |
| Open-label baseline score [mean (SD)] | |||
| PANSS total | 80.5 (15.80) | 75.3 (14.50) | 86.4 (15.17) |
| Positive subscale | 19.0 (5.31) | 17.6 (4.45) | 20.6 (5.74) |
| Negative subscale | 20.7 (4.49) | 19.4 (4.45) | 22.0 (4.16) |
| General Psychopathology Subscale | 40.9 (8.29) | 38.3 (7.92) | 43.8 (7.73) |
| CGI-S | 3.9 (0.89) | 3.6 (0.78) | 4.1 (0.93) |
| CDSS | 2.4 (2.85) | 2.0 (2.33) | 2.9 (3.28) |
Notes: Modal 40 mg group: Subjects who received 40 mg for most days during the extension phase. Modal 80 mg group: Subjects who received 80 mg for most days during the extension phase.
Abbreviations: PANSS, Positive and Negative Syndrome Scale, CGI-S, Clinical Global Impressions – Severity scale; CDSS, Calgary Depression Scale for Schizophrenia; ITT, intention-to-treat; SD, standard deviation.