Table 2.
Summary of Outcomes.
| Outcome | With Manic Symptoms (n = 808) | Without Manic Symptoms (n = 575) | ||||
|---|---|---|---|---|---|---|
| Cariprazine | Cariprazine | |||||
| PBO (n = 262) |
1.5 mg/d (n = 275) |
3 mg/d (n = 271) |
PBO (n = 198) |
1.5 mg/d (n = 186) |
3 mg/d (n = 191) |
|
| LSMD vs PBO at week 6, a mean (SE) | ||||||
| MADRS total score | — | −2.51 (0.85)** | −2.86 (0.86)*** | — | −3.30 (0.98)*** | −1.85 (0.97) |
| CGI-S score | — | −0.24 (0.10)* | −0.25 (0.10)* | — | −0.40 (0.12)*** | −0.26 (0.12)* |
| HAMD17 total score | — | −1.86 (0.65)** | −1.55 (0.67)* | — | −2.21 (0.77)** | −1.32 (0.77) |
| YMRS total score | — | −0.20 (0.28) | −0.37 (0.28) | — | −0.22 (0.26) | 0.02 (0.26) |
| Response/remission at week 6, b n (%) | ||||||
| MADRS responders | 99 (37.8) | 128 (46.6)* | 135 (49.8)** | 66 (33.3) | 84 (45.2)* | 80 (41.9) |
| Odds ratio | — | 1.43 | 1.64 | — | 1.67 | 1.48 |
| MADRS remitters | 55 (21.0) | 86 (31.3)** | 85 (31.4)** | 41 (20.7) | 60 (32.3)** | 48 (25.1) |
| Odds ratio | — | 1.74 | 1.76 | — | 1.89 | 1.35 |
| CGI-S remitters | 60 (22.9) | 83 (30.2)* | 79 (29.2)* | 38 (19.2) | 55 (29.6)*** | 48 (25.1)** |
| Odds ratio | — | 1.45 | 1.40 | — | 1.90 | 1.62 |
| HAMD17 remitters c | 43 (17.1) | 82 (31.8)*** | 58 (22.3) | 35 (19.3) | 51 (30.0)* | 40 (22.4) |
| Odds Ratio | — | 2.26 | 1.42 | — | 1.81 | 1.22 |
| Treatment-emergent mania at any postbaseline visit, n (%) | ||||||
| YMRS total score ≥16 | 6 (2.3) | 5 (1.8) | 2 (0.7) | 3 (1.5) | 2 (1.1) | 2 (1.0) |
a
Analyzed using MMRM.
b
Logistic regression using LOCF.
c
Number of patients included in the HAMD17 remission analysis were different than the ITT population (patients with manic symptoms: PBO=251, 1.5 mg/day = 258, 3 mg/day = 254; patients without manic symptoms: PBO=181, 1.5 mg/day = 170, 3 mg/day = 179).
Note: *p < .05, **p < .01, ***p ≤ .001 vs placebo.
Abbreviations: CGI-S, Clinical Global Impressions-Severity Rating Scale; HAMD17, 17-item Hamilton Depression Rating Scale; ITT, intent-to-treat; LOCF, last observation carried forward; LSMD, least squares mean difference; MADRS, Montgomery-Åsberg Depression Rating Scale; MMRM, mixed model for repeated measures; PBO, placebo; SE, standard error; YMRS, Young Mania Rating Scale.