Table 1.
Demographic characteristics in the GAPP-MDD clinical trial at baseline by treatment in the per-protocol cohort.
| Demographics | Treatment | Total (N = 276) | p-value | ||
|---|---|---|---|---|---|
| TAU (N = 93) | GEN (N = 90) | E-GEN (N = 93) | |||
| Age group, n (%) | |||||
| 18 to 34 | 35 (37.6) | 42 (46.7) | 32 (34.4) | 109 (39.5) | 0.21 |
| 35 to 49 | 27 (29.0) | 21 (23.3) | 32 (34.4) | 80 (29.0) | 0.26 |
| 50 to 64 | 25 (26.9) | 20 (22.2) | 25 (26.9) | 70 (25.4) | 0.71 |
| 65 and over | 6 (6.5) | 7 (7.8) | 4 (4.3) | 17 (6.2) | 0.61 |
| Age | |||||
| Mean (SD) | 42.3 (14.2) | 40.3 (15.3) | 40.7 (12.9) | 41.1 (14.1) | 0.62 |
| Min, Max | 20.0, 78.0 | 19.0, 76.0 | 18.0, 69.0 | 18.0, 78.0 | – |
| Gender, n (%) | |||||
| Female | 59 (63.4) | 59 (65.6) | 60 (64.5) | 178 (64.5) | 0.96 |
| Male | 34 (36.6) | 31 (34.4) | 33 (35.5) | 98 (35.5) | 0.96 |
| Ethnicity, n (%)a | |||||
| Asian | 7 (7.5) | 10 (11.1) | 7 (7.5) | 24 (8.7) | 0.61 |
| Black | 1 (1.1) | 3 (3.3) | 4 (4.3) | 8 (2.9) | 0.40 |
| Caucasian | 83 (89.2) | 72 (80.0) | 77 (82.8) | 232 (84.1) | 0.21 |
| Latin American | 2 (2.2) | 2 (2.2) | 1 (1.1) | 5 (1.8) | 0.81 |
| Other | 0 | 3 (3.3) | 4 (4.3) | 7 (2.5) | 0.15 |
| Depression category, n (%) | |||||
| Moderate (HAM-D17 14–18) | 28 (30.1) | 26 (28.9) | 30 (32.3) | 84 (30.4) | 0.88 |
| Severe (HAM-D17 19–22) | 25 (26.9) | 24 (26.7) | 27 (29.0) | 76 (27.5) | 0.92 |
| Very severe (HAM-D17 > 22) | 40 (43.0) | 40 (44.4) | 36 (38.7) | 116 (42.0) | 0.71 |
| Psychiatric comorbidities, n (%) | |||||
| Generalized anxiety disorder | 35 (37.6) | 45 (50.0) | 38 (40.9) | 119 (43.1) | 0.23 |
| Panic disorder | 8 (8.6) | 15 (16.7) | 15 (16.1) | 38 (13.8) | 0.21 |
| Post-traumatic stress disorder | 7 (7.5) | 7 (7.8) | 8 (8.6) | 22 (8.0) | 0.96 |
| HAM-D17 | |||||
| Mean (SD) | 21.4 (4.5) | 21.3 (4.7) | 21.5 (4.8) | 21.4 (4.7) | 0.99 |
| Min, Max | 14.0, 36.0 | 14.0, 36.0 | 14.0, 33.0 | 14.0, 36.0 | – |
| Number of failed psych meds, n | |||||
| 1 | 28 | 14 | 20 | 62 | 0.0598 |
| 2 | 20 | 23 | 15 | 58 | 0.29 |
| 3 | 12 | 8 | 14 | 34 | 0.44 |
| 4 | 9 | 17 | 8 | 34 | 0.07 |
| 5 | 8 | 7 | 10 | 25 | 0.77 |
| 6+ | 13 | 20 | 24 | 57 | 0.12 |
| Missingb | 3 | 1 | 2 | 6 | 0.62 |
| Mean (SD) | 3.0 (2.2) | 3.7 (2.2) | 4.0 (3.1) | 3.6 (2.6) | 0.0388 |
| Min, Max | 1.0, 9.0 | 1.0, 8.0 | 1.0, 21.0 | 1.0, 21.0 | – |