Asenapine (n = 379)* | Placebo (n = 202)* | Olanzapine (n = 396)* | |
---|---|---|---|
Patient populations, n | |||
Patients with mixed episodes† | 111 | 67 | 124 |
Patients with MADRS total score ≥20‡ | 45 | 33 | 54 |
Patients with CGI-BP-D severity score ≥4§ | 59 | 37 | 74 |
Men, n (%) | |||
Patients with mixed episodes† | 63 (56.8) | 30 (44.8) | 70 (56.5) |
Patients with MADRS total score≥20‡ | 22 (48.9) | 16 (48.5) | 26 (48.1) |
Patients with CGI-BP-D severity score ≥4§ | 31 (52.5) | 18 (48.6) | 37 (50) |
Mean ± SD age, y | |||
Patients with mixed episodes† | 38.3 ± 11.2 | 39.5 ± 12.5 | 38.8 ± 10.4 |
Patients with MADRS total score ≥20‡ | 38.3 ± 11.5 | 41.2 ± 11.6 | 39.5 ± 11.1 |
Patients with CGI-BP-D severity score ≥4§ | 39.4 ± 11.8 | 36.9 ± 12.7 | 39.6 ± 9.7 |
Mean ± SD daily dose, mg | |||
Patients with mixed episodes† | 18.2 ± 2.8 | - | 15.6 ± 2.3 |
Patients with MADRS total score ≥20‡ | 18.3 ± 2.7 | - | 16.3 ± 2.5 |
Patients with CGI-BP-D severity score ≥4§ | 17.9 ± 2.6 | - | 15.9 ± 2.5 |
Mean ± SD MADRS total score | |||
Patients with mixed episodes† | 16.7 ± 6.3 | 18.8 ± 7.3 | 16.9 ± 6.9 |
Patients with MADRS total score ≥20‡ | 24.4 ± 3.5 | 25.8 ± 4.7 | 24.7 ± 4.4 |
Patients with CGI-BP-D severity score ≥4§ | 20.2 ± 6.9 | 22.2 ± 7.5 | 19.7 ± 7.2 |
Mean ± SD CGI-BP-D severity score | |||
Patients with mixed episodes† | 3.1 ± 1.3 | 3.4 ± 1.1 | 3.2 ± 1.1 |
Patients with MADRS total score ≥20‡ | 3.9 ± 0.9 | 3.8 ± 0.9 | 3.8 ± 0.8 |
Patients with CGI-BP-D severity score ≥4§ | 4.4 ± 0.6 | 4.3 ± 0.5 | 4.2 ± 0.4 |
Discontinuations, n (%) | |||
Patients with mixed episodes,† overall | 44 (39.6) | 24 (35.8) | 31 (25.0) |
Adverse events | 12 (10.8) | 1 (1.5) | 7 (5.6) |
Lack of efficacy | 8 (7.2) | 8 (11.9) | 7 (5.6) |
Lost to follow-up | 2 (1.8) | 1 (1.5) | 6 (4.8) |
Withdrew consent | 20 (18.0) | 12 (17.9) | 11 (8.9) |
Other | 2 (1.8) | 2 (3.0) | 0 (0) |
Patients with MADRS total score ≥20,‡ overall | 19 (42.2) | 11 (33.3) | 13 (24.1) |
Adverse events | 6 (13.3) | 1 (3.0) | 2 (3.7) |
Lack of efficacy | 2 (4.4) | 5 (15.2) | 7 (13.0) |
Lost to follow-up | 2 (4.4) | 0 (0) | 1 (1.9) |
Withdrew consent | 8 (17.8) | 4 (12.1) | 3 (5.6) |
Other | 1 (2.2) | 1 (3.0) | 0 (0) |
Patients with CGI-BP-D severity score ≥4,§ overall | 26 (44.1) | 14 (37.8) | 19 (25.7) |
Adverse events | 6 (10.2) | 1 (2.7) | 4 (5.4) |
Lack of efficacy | 4 (6.8) | 4 (10.8) | 8 (10.8) |
Lost to follow-up | 1 (1.7) | 1 (2.7) | 3 (4.1) |
Withdrew consent | 13 (22.0) | 7 (18.9) | 4 (5.4) |
other | 2 (3.4) | 1 (2.7) | 0 (0) |