TABLE 1.
Short-Term Studies—Mean Changes From Baseline in Prolactin (ng/mL) by Sex and Baseline Prolactin Status
| Sex | Females | Males | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline Status | Low | Normal | >1× ULN | Low | Normal | >1× ULN | ||||||
| Treatment | Placebo | Brexpiprazole 1–3 mg | Placebo | Brexpiprazole 1–3 mg | Placebo | Brexpiprazole 1–3 mg | Placebo | Brexpiprazole 1–3 mg | Placebo | Brexpiprazole 1–3 mg | Placebo | Brexpiprazole 1–3 mg |
| Baseline | ||||||||||||
| Mean | 2.29 | 2.17 | 9.68 | 9.66 | 33.72 | 31.92 | 2.42 | 2.44 | 7.26 | 7.23 | 17.46 | 18.24 |
| (SD) | (0.31) | (0.79) | (4.70) | (4.38) | (6.18) | (4.65) | (0.04) | (0.07) | (2.41) | (2.29) | (5.32) | (5.11) |
| [Median] | [2.30] | [2.17] | [8.29] | [8.70] | [32.05] | [31.57] | [2.42] | [2.44] | [7.09] | [6.92] | [16.63] | [16.48] |
| n | 4 | 2 | 398 | 555 | 10 | 11 | 2 | 2 | 166 | 222 | 11 | 16 |
| Change week 6 | ||||||||||||
| Mean | 1.31 | 4.87 | 0.27 | 7.75 | −13.08 | −7.34 | 0.86 | 2.36 | 0.22 | 2.29 | 0.39 | −3.55 |
| (SD) | (1.00) | (0.86) | (4.75) | (8.60) | (10.74) | (13.51) | (0.99) | (2.06) | (2.62) | (3.68) | (9.05) | (8.81) |
| [Median] | [1.35] | [4.87] | [−0.15] | [6.19] | [−14.03] | [−12.88] | [0.86] | [2.36] | [0.04] | [1.71] | [1.90] | [−1.99] |
| n | 4 | 2 | 381 | 522 | 9 | 10 | 2 | 2 | 156 | 207 | 11 | 15 |