Table 2.
Change in clinical stability indicators during the AOM 400 maintenance phase
| Mean (SD) change from baseline to last visit (up to week 52; LOCF) | ||||||
|---|---|---|---|---|---|---|
| Assessment | De novo | Rollover | Total | |||
| N | Result | N | Result | N | Result | |
| YMRS total score | 377 | − 0.33 (3.87) | 85 | − 0.16 (4.42) | 462 | − 0.30 (3.97) |
| MADRS total score | 377 | 1.36 (6.93) | 85 | 0.67 (3.16) | 462 | 1.24 (6.41) |
| CGI-BP-S overall score | 353 | 0.13 (1.20) | 84 | − 0.01 (0.69) | 437 | 0.10 (1.12) |
| CGI-BP-S mania score | 353 | − 0.07 (0.83) | 84 | − 0.08 (0.71) | 437 | − 0.07 (0.81) |
| CGI-BP-S depression score | 353 | 0.18 (1.14) | 84 | 0.12 (0.52) | 437 | 0.17 (1.05) |
AOM 400 aripiprazole once-monthly 400 mg, CGI-BP-S Clinical Global Impressions for Bipolar Disorder-Severity of Illness Scale, LOCF last observation carried forward, MADRS Montgomery–Asberg Depression Rating Scale, SD standard deviation, YMRS Young Mania Rating Scale