Table 1. Demographics and Baseline Characteristics.
| No. (%) | |||
|---|---|---|---|
| Sublingual dexmedetomidine | Placebo (n = 126) | ||
| 180 μg (n = 126) | 120 μg (n = 126) | ||
| Age, y | |||
| Mean (SD) | 45.9 (11.3) | 46.1 (11.5) | 44.8 (12.1) |
| Median (range) | 47 (18-69) | 49 (19-70) | 48 (18-67) |
| Women | 67 (53.2) | 67 (53.2) | 73 (57.9) |
| Men | 59 (46.8) | 59 (46.8) | 53 (42.1) |
| Race | |||
| Asian | 1 (0.8) | 0 | 2 (1.6) |
| Black or African American | 72 (57.1) | 68 (54.0) | 72 (57.1) |
| Multiple | 3 (2.4) | 1 (0.8) | 1 (0.8) |
| White | 49 (38.9) | 56 (44.4) | 50 (39.7) |
| Othera | 1. (0.8) | 1 (0.8) | 1 (0.8) |
| Hispanic or Latino | 15 (11.9) | 12 (9.5) | 11 (8.7) |
| Body weight, kg | |||
| Mean (SD) | 96.8 (26.0) | 91.8 (25.9) | 92.0 (20.7) |
| Median (range) | 93.8 (54.8-200.1) | 87.6 (49.9-274.0) | 90.7 (48.0-150.8) |
| BMI | |||
| Mean (SD) | 33.3 (8.7) | 31.6 (8.0) | 32.5 (7.4) |
| Median (range) | 31.7 (19.0-66.9) | 29.8 (18.0-78.4) | 31.8 (16.8-59.6) |
| Diagnosis | |||
| Mania | 59 (46.8) | 58 (46.0) | 63 (50.0) |
| Depressed | 28 (22.2) | 20 (15.9) | 26 (20.6) |
| Mixed episodes | 30 (23.8) | 27 (21.4) | 22 (17.5) |
| Hypomania | 5 (4.0) | 14 (11.1) | 10 (7.9) |
| Unspecified | 4 (3.2) | 7 (5.6) | 5 (4.0) |
| Current agitation episode, d | |||
| Mean (SD) | 25.1 (74.3) | 21.8 (31.3) | 15.7 (21.8) |
| Median (range) | 9 (1-730) | 7 (1-192) | 7 (1-132) |
| No. of hospitalizations | |||
| Mean (SD) | 2.8 (4.4) | 3.5 (4.7) | 2.8 (3.7) |
| Median (range) | 1 (0-20) | 2 (0-22) | 2 (0-20) |
| Hours of sleep/night this wk | |||
| Mean (SD) | 5.1 (1.5) | 5.3 (1.6) | 5.1 (1.5) |
| Median (range) | 5 (1-9) | 5 (2-10) | 5 (1-10) |
| Current smoker | 78 (61.9) | 97 (77.0) | 83 (65.9) |
| PEC scoreb | |||
| Mean (SD)c | 18.0 (3.0) | 18.0 (2.7) | 17.9 (2.9) |
| Median (range) | 17.5 (14-28) | 17.0 (14-27) | 17.0 (14-30) |
| CGI-Sd | |||
| Mean (SD)c | 4.1 (0.7) | 4.1 (0.5) | 4.1 (0.6) |
| Median (range) | 4 (2-6) | 4 (3-5) | 4 (1-6) |
Abbreviations: BMI, body mass index, calculated as weight in kilograms divided by height in meters squared; CGI-S, Clinical Global Impressions–Severity of Illness; PEC, Positive and Negative Syndrome Scale-Excited Component.
Participants self-identified race and ethnicity. No participant identified themselves as American Indian or Alaska Native, Native Hawaiian, or Other Pacific Islander. A participant could select the category “other” if none of the other categories was appropriate.
Comprises 5 items with a range of 5 (absence of agitation) to 35 (extremely severe).
The mean baseline PEC score in these data corresponds to the CGI-S score of moderately ill. A moderately ill individual would have PEC subscale items of moderate severity (poor impulse control, tension, hostility, uncooperativeness, and excitement).
Scores are rated on a 7-point scale, with a range of responses from 1 (normal) to 7 (among the most severely ill patients).