Table 1 Characteristics of patients at open-label baseline (safety population).

From: Safety and effectiveness of ulotaront (SEP-363856) in schizophrenia: results of a 6-month, open-label extension study

Characteristic

DB-placebo → OL-ulotaront (N = 79)

DB-ulotaront → OL-ulotaront (N = 77)b

Male, n (%)

50 (63.3)

52 (67.5)

Agea, years, mean (SD)

30.2 (6.4)

30.2 (5.7)

Race, n (%)

 White

73 (92.4)

63 (81.8)

 Black

5 (6.3)

10 (13.0)

 Other

1 (1.3)

4 (5.2)

Hispanic, n (%)

4 (5.1)

1 (1.3)

Body mass index, kg/m2, mean (SD)

24.3 (3.2)

25.9 (4.3)

Time since initial onset of schizophreniaa, years, mean (SD)

4.3 (4.0)

5.2 (4.6)

Prior psychiatric hospitalizationsa

Mean (SD)

1.2 (0.8)

1.3 (0.7)

None, n (%)

18 (22.8)

11 (14.3)

  1. DB double-blind, OL open-label.
  2. aAge, time since initial onset of schizophrenia, and number of prior psychiatric hospitalizations are calculated at entry into the initial double-blind study.
  3. bOne patient discontinued without receiving a dose of study medication and was excluded from all safety and efficacy analyses.
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