Table 1.
Patient Demographic and Clinical Characteristics (ITT population)
| Dasotraline 4 mg/d (N = 161) | Dasotraline 6 mg/d (N = 162) | Placebo (N = 162) | |
|---|---|---|---|
| Age, mean (SD), years | 36.9 (9.6) | 38.9 (9.7) | 37.1 (10.2) |
| Female, n (%) | 138 (85.7) | 133 (82.1) | 136 (84.0) |
| Race, n (%) | |||
| White | 119 (73.9) | 121 (74.7) | 130 (80.2) |
| Black/African American | 25 (15.5) | 32 (19.8) | 29 (17.9) |
| Asian | 7 (4.3) | 4 (2.5) | 1 (0.6) |
| Other | 10 (6.2) | 5 (3.1) | 2 (1.2) |
| Ethnicity, n (%) | |||
| Hispanic/Latino | 31 (19.3) | 26 (16.0) | 28 (17.3) |
| Weight, kg, mean (SD) | 96.9 (19.7) | 96.0 (18.0) | 96.9 (20.8) |
| BMI, kg/m2, mean (SD) a | 34.8 (6.1) | 34.3 (5.7) | 34.5 (6.3) |
| Normal/Underweight (<25), n (%) | 9 (5.6) | 8 (4.9) | 12 (7.4) |
| Overweight (25 to < 30), n (%) | 32 (19.9) | 30 (18.5) | 28 (17.3) |
| Obesity class I (30 to <35), n (%) | 41 (25.5) | 48 (29.6) | 42 (25.9) |
| Obesity class II (35 to <40), n (%) | 46 (28.6) | 45 (27.8) | 46 (28.4) |
| Obesity class III (≥40), n (%) | 33 (20.5) | 31 (19.1) | 34 (21.0) |
| Age, initial symptoms, mean (SD), years | 23.8 (10.8) | 24.1 (11.3) | 24.2 (11.2) |
| Age, initial diagnosis, mean (SD), years | 36.7 (9.7) | 38.3 (10.2) | 36.8 (10.4) |
| Binge eating days/week, mean (SD) | 4.2 (1.1) | 4.2 (1.1) | 4.3 (1.0) |
| Binge eating episodes/week, mean (SD) | 5.4 (3.5) | 5.4 (3.0) | 5.6 (2.8) |
| BE-CGI-S score, mean (SD) | 4.5 (0.5) | 4.4 (0.5) | 4.4 (0.5) |
| YBOCS-BE total score, mean (SD) | 21.6 (3.7) | 21.6 (4.3) | 21.9 (3.7) |
Abbreviations: BMI, body mass index; BE-CGI-S, binge-eating Clinical Global Impression–Severity; ITT, intention-to-treat; SD, standard deviation; YBOCS-BE, Yale-Brown Obsessive–Compulsive Scale Modified for Binge-eating
a
BMI categories based on NIH criteria. 41