TABLE 2.
Long-Term Study—Mean Changes From Baseline in Prolactin (ng/mL) by Sex, Baseline Prolactin Status, and Prior Treatment
Baseline Status | Low | Normal | >1× ULN | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Treatment | Prior placebo | Prior brexpiprazole | Prior ADT | Prior quetiapine | Prior placebo | Prior brexpiprazole | Prior ADT | Prior quetiapine | Prior placebo | Prior brexpiprazole | Prior ADT | Prior quetiapine | |
Females | |||||||||||||
Baseline | |||||||||||||
Mean | 2.33 | — | 2.15 | — | 9.40 | 13.81 | 9.87 | 9.03 | 40.32 | 39.63 | 42.43 | 39.16 | |
(SD) | (0.19) | (0.75) | (4.62) | (5.97) | (4.82) | (4.16) | (28.76) | (21.00) | (22.94) | (19.94) | |||
[Median] | [2.28] | [2.45] | [8.56] | [13.62] | [8.59] | [8.49] | [29.96] | [34.20] | [32.43] | [30.23] | |||
n | 3 | 14 | 345 | 421 | 1040 | 45 | 15 | 53 | 34 | 4 | |||
Change week 26; | |||||||||||||
Mean | 5.23 | — | 3.81 | — | 5.94 | 0.64 | 3.63 | 3.27 | −8.72 | −14.81 | −18.29 | −25.22 | |
(SD) | (0) | (2.68) | (9.92) | (15.11) | (7.86) | (6.45) | (33.02) | (28.39) | (28.30) | (23.93) | |||
[Median] | [5.23] | [3.54] | [4.99] | [−0.98] | [2.30] | [2.54] | [−4.73] | [−12.73] | [−13.62] | [−16.80] | |||
n | 1 | 10 | 225 | 284 | 754 | 34 | 10 | 33 | 26 | 4 | |||
Change week 52; | |||||||||||||
Mean | — | — | 2.29 | — | 4.08 | −2.20 | 3.01 | 1.66 | −13.56 | −12.57 | −8.18 | — | |
(SD) | (0) | (7.22) | (7.00) | (6.05) | (0) | (2.50) | (12.41) | (21.21) | |||||
[Median] | [2.29] | [2.70] | [−2.41] | [2.20] | [1.66] | [−14.28] | [−12.20] | [−9.84] | |||||
n | 1 | 113 | 180 | 184 | 1 | 4 | 22 | 6 | |||||
Males | |||||||||||||
Baseline | |||||||||||||
Mean | 1.62 | 1.96 | 1.85 | — | 6.88 | 8.04 | 7.07 | 6.64 | 20.54 | 17.67 | 23.05 | 30.31 | |
(SD) | (0.96) | (0.75) | (0.92) | (2.63) | (2.38) | (2.46) | (2.01) | (8.91) | (4.91) | (13.61) | (21.39) | ||
[Median] | [2.01] | [1.96] | [2.26] | [6.54] | [8.19] | [6.69] | [6.14] | [18.21] | [15.85] | [16.99] | [30.31] | ||
n | 5 | 2 | 10 | 125 | 185 | 457 | 23 | 17 | 37 | 66 | 2 | ||
Change week 26; | |||||||||||||
Mean | 5.57 | 5.50 | 2.53 | — | 2.24 | 0.66 | 2.11 | 6.87 | −7.14 | −1.80 | −4.44 | — | |
(SD) | (7.01) | (0) | (1.55) | (3.39) | (5.05) | (5.08) | (10.06) | (13.16) | (9.10) | (13.98) | |||
[Median] | [3.34] | [5.50] | [2.69] | [1.89] | [−0.21] | [1.37] | [2.32] | [−4.80] | [−2.75] | [−3.05] | |||
n | 4 | 1 | 7 | 86 | 118 | 337 | 13 | 13 | 24 | 53 | |||
Change week 52; | |||||||||||||
Mean | 1.48 | — | 2.81 | — | 2.97 | 0.35 | 1.07 | — | −5.78 | −5.01 | −1.63 | — | |
(SD) | (0.73) | (2.88) | (5.62) | (4.03) | (3.32) | (4.08) | (5.36) | (17.27) | |||||
[Median] | [1.48] | [2.81] | [1.41] | [−0.40] | [0.89] | [−6.43] | [−4.07] | [−3.09] | |||||
n | 2 | 2 | 46 | 71 | 74 | 8 | 20 | 16 |