Table 1 Baseline demographics and clinical characteristics
Characteristic | Placebo n = 199 | Armodafinil 150 mg/day n = 200 |
|---|---|---|
Age, years, mean (SD) | 43.7 (11.6) | 45.3 (11.3) |
Males, n (%) | 78 (39) | 80 (40) |
Race, n (%) | ||
White | 176 (88) | 182 (91) |
Black | 16 (8) | 14 (7) |
Other | 7 (4) | 4 (2) |
Weight, kg, mean (SD) | 81.2 (17.5) | 80.7 (17.5) |
IDS-C30 total score, mean (SD) | 43.3 (7.7) | 42.4 (7.7) |
QIDS-C16 total score, mean (SD) | 16.8 (2.7) | 16.1 (2.7) |
CGI-S score, mean (SD) | 4.6 (0.6) | 4.6 (0.7) |
GAF score, mean (SD) | 54.8 (6.7) | 53.6 (8.9) |
C-SSRS | ||
Suicidal behavior, n (%) | ||
Suicidal behavior, actual attempt | 20 (10) | 21 (11) |
Non-suicidal self-injurious behavior | 7 (4) | 6 (3) |
Interrupted attempt | 3 (2) | 2 (1) |
Aborted attempt | 4 (2) | 4 (2) |
Suicidal behavior | 4 (2) | 4 (2) |
Preparatory acts or behavior | 5 (3) | 6 (3) |
Suicidal ideation, n (%) | ||
Suicidal ideation, wish to be dead | 27 (14) | 37 (19) |
Non-specific active suicidal thoughts | 16 (8) | 24 (12) |
Any methods (no plan) without intent to act | 12 (6) | 20 (10) |
Some intent to act without specific plan | 9 (5) | 14 (7) |
Specific plan and intent | 10 (5) | 15 (8) |
YMRS total score, mean (SD) | 3.7 (2.1) | 3.7 (2.2) |
HAM-A total score, mean (SD) | 12.6 (2.8) | 12.5 (2.9) |
ISI total score, mean (SD) | 16.1 (5.2) | 15.7 (5.5) |