Table 1.
Baseline characteristics of randomized patients.
| TCOAD (N=202) | PLACEBO (N=204) | P VALUE | |
|---|---|---|---|
| DEMOGRAPHICS | |||
| Gender (n) | > 0.99 | ||
| Male | 73 (36.1%) | 73 (35.8%) | |
| Female | 129 (63.9%) | 131 (64.2%) | |
| Age (years) | |||
| Mean (SD) | 43.8 (12.8) | 44.0 (13.5) | 0.87 |
| Ethnic origin (n) | Caucasian: 139 (68.8%) Black: 41 (20.3%) Asian: 4 (2.0%) Other: 18 (8.9%) |
Caucasian: 140 (68.6%) Black: 44 (21.6%) Asian: 3 (1.5%) Other: 17 (8.3%) |
0.97 |
| CLINICAL CHARACTERISTICS | |||
| HAMD-17 total score [mean (SD)] | 23.2 (4.2) | 22.4 (4.4) | 0.08 |
| MADRS total score [mean (SD)] | 32.6 (4.1) | 31.9 (4.3) | 0.21 |
| Clinical global impression, severity of illness (n) |
Mildly ill: 0 Moderately ill: 95 (47.0%) Markedly ill: 104 (51.5%) Severely ill: 3 (1.5%) |
Mildly ill: 1 (0.5%) Moderately ill: 115 (56.4%) Markedly ill: 85 (41.7%) Severely ill: 3 (1.5%) |
0.13 |
| Overall quality of sleep (n) | Excellent: 2 (1.0%) Good: 13 (6.4%) Fair: 91 (45.0%) Very poor: 96 (47.5%) |
Excellent: 3 (1.5%) Good: 17 (8.3%) Fair: 85 (41.7%) Very poor: 99 (48.5%) |
0.8 |
| Trouble falling asleep (n) | Never: 15 (7.4%) Rarely: 25 (12.4%) Frequently: 98 (48.5%) Always: 64 (31.7%) |
Never: 18 (8.8%) Rarely: 37 (18.1%) Frequently: 90 (44.1%) Always: 59 (28.9%) |
0.37 |
| Awakening during the night (n) | Never: 6 (3.0%) Rarely: 26 (12.9%) Frequently: 90 (44.6%) Always: 80 (39.6%) |
Never: 6 (2.9%) Rarely: 28 (13.7%) Frequently: 90 (44.1%) Always: 80 (39.2%) |
> 0.99 |
TCOAD=Trazodone Contramid OAD