Table 1.
Baseline demographics and clinical characteristics by treatment group (N = 60)
| N (col %) or Mean [SD] |
||||
|---|---|---|---|---|
| Characteristic | Total sample | Drug | Placebo | p-value* |
| Gender | 1.000 | |||
| Male | 20 (33.3) | 10 (33.3) | 10 (33.3) | |
| Female | 40 (66.7) | 20 (66.7) | 20 (66.7) | |
| Age | 41.5 [12.5] | 44.9 [11.7] | 38.0 [12.5] | 0.031 |
| Race | 0.660 | |||
| Caucasian | 46 (76.7) | 22 (73.3) | 24 (80) | |
| African American | 12 (20) | 6 (20) | 6 (20) | |
| Other | 2 (3.3) | 2 (6.7) | 0 (0) | |
| Marital Status | 0.609 | |||
| Married/ Living with Someone | 23 (38.3) | 13 (43.3) | 10 (33.3) | |
| Separated/Divorced/Widowed | 22 (36.7) | 11 (36.7) | 11 (36.7) | |
| Never Married | 15 (25) | 6 (20) | 9 (30) | |
| Years of Education | 0.104 | |||
| < High School | 5 (8.3) | 1 (3.3) | 4 (13.3) | |
| High School Diploma/GED | 22 (36.7) | 14 (46.7) | 8 (26.7) | |
| Associate Degree | 9 (15) | 4 (13.3) | 5 (16.7) | |
| Bachelor’s Degree | 16 (26.7) | 5 (16.7) | 11 (36.7) | |
| Master’s/ Doctorate Degree | 8 (13.3) | 6 (20) | 2 (6.7) | |
| Body mass index (BMI) | 27.8 [4.9] | 27.0 [4.8] | 28.6 [5.2] | 0.237 |
| Mini Mental State Exam (MMSE) | 29.4 [0.9] | 29.4 [0.8] | 29.5 [1.0] | 0.779 |
| Age at first lifetime major depressive episode | 29.9 [13.1] | 32.3 [12.8] | 27.6 [13.2] | 0.167 |
| Number of prior lifetime major depressive episodes | 0.673 | |||
| 0 Episodes | 2 (3.3) | 0 (0) | 2 (6.7) | |
| 1 Episode | 15 (25) | 7 (23.3) | 8 (26.7) | |
| 2 Episodes | 18 (30) | 8 (26.7) | 10 (33.3) | |
| 3 Episodes | 11 (18.3) | 6 (20) | 5 (16.7) | |
| 4 Episodes | 7 (11.7) | 4 (13.3) | 3 (10) | |
| 5 Episodes | 7 (11.7) | 5 (16.7) | 2 (6.7) | |
| Duration of present episode of major depression (in weeks) | 169.6 [310.1] | 185.5 [349.4] | 153.8 [270.3] | 0.695 |
| Duration of insomnia complaint (in weeks) | 165.5 [322.7] | 207.2 [400.2] | 123.8 [219.2] | 0.322 |
| SCID: MDE Specifier | 0.707 | |||
| None | 17 (28.3) | 8 (26.7) | 9 (30) | |
| Melancholic | 39 (65) | 19 (63.3) | 20 (66.7) | |
| Atypical | 4 (6.7) | 3 (10) | 1 (3.3) | |
| Psychiatric DOS | ||||
| Dysthymic Disorder (No) | 60 (100) | 30 (100) | 30 (100) | --- |
| Presence of any lifetime dependence or abuse (yes) | 22 (36.7) | 11 (36.7) | 11 (36.7) | 1.000 |
| Presence of any anxiety disorder (yes) | 32 (53.3) | 13 (43.3) | 19 (63.3) | 0.120 |
| Index | Total sample mean [SD] | Drug (N = 30) mean [SD] | Placebo (N = 30) mean [SD] | p-value* |
| 24-item Hamilton Rating Scale for Depression | 27.1 [3.9] | 27.3 [3.3] | 26.9 [4.5] | 0.744 |
| 21-item HRSD (no insomnia items) | 22.4 [3.8] | 22.6 [3.3] | 22.3 [4.3] | 0.762 |
| Sum of HRSD insomnia items | 4.7 [1.2] | 4.7 [1.1] | 4.7 [1.2] | 0.912 |
| PHQ-9 Total Score | 16.6 [4.3] | 16.7 [4.3] | 16.5 [4.4] | 0.860 |
| Beck Anxiety Index | 16.0 [8.5] | 15.1 [7.5] | 6.8 [9.4] | 0.442 |
| ISI Total Score | 20.7 [4.0] | 21.1 [4.0] | 20.2 [4.1] | 0.429 |
| Basis 32 Daily Living and Role Function (DLRF) Visit 2 | 2.0 [0.7] | 1.9 [0.7] | 2.0 [0.7] | 0.628 |
| Basis 32 Relationship to Self and Others (RSO) Visit 2 | 1.9 [0.8] | 1.8 [0.7] | 2.0 [0.8] | 0.582 |
| Q-LES-Q Total Score | 38.7 [6.9] | 38.8 [7.2] | 38.6 [6.7] | 0.897 |
*
p-value from Fisher exact test for categorical variables and t-test for continuous variables. Tests compared drug and placebo participant groups.