Table 1.
Baseline characteristics of study participants enrolled in the randomized double-blind phase
| Placebo | R-107 30 mg | R-107 60 mg | R-107 120 mg | R-107 180 mg | P value for difference between treatment groups | ||
|---|---|---|---|---|---|---|---|
| n | 37 | 34 | 34 | 31 | 32 | N/A | |
| Age, years | Mean (s.d.) | 43.7 (15.43) | 44.6 (12.89) | 42.5 (15.80) | 47.2 (13.80) | 46.8 (11.90) | 0.6063 |
| Median (IQR) | 42 (31–57) | 45.5 (34.75–51.5) | 40.5 (28.5–53.75) | 48 (33.5–60) | 46 (36–56.25) | N/A | |
| Sex (M/F) | 22/15 | 18/16 | 18/16 | 13/18 | 21/11 | 0.4096 | |
| Number of prior depressive episodes | Mean (s.d.) | 3.9 (7.42) | 3.2 (4.33) | 3.1 (3.21) | 4.4 (4.67) | 1.8 (1.59) | 0.3526 |
| Median (IQR) | 1 (1–3) | 1 (1–3) | 1 (1–4.5) | 2 (1–4) | 1 (1–2) | N/A | |
| Treatment resistance—mean number of past failed ADs in this episode | Mean (SD) | 4.8 (2.84) | 5.0 (2.74) | 4.6 (2.70) | 4.8 (3.39) | 4.7 (2.74) | 0.9871 |
| Median (IQR) | 4 (3–5.75) | 5 (2.5–6) | 4 (2.25–6) | 3.5 (2–5.75) | 4 (3–6) | N/A | |
| Failed ECT pre-study (%) | 2 (5.4%) | 4 (11.8%) | 1 (2.9%) | 5 (16.1%) | 2 (6.2%) | 0.3372 | |
| Number taking ADs pre-study entry (%) | 34 (91.9%) | 32 (94.1%) | 31 (91.2%) | 31 (100.0%) | 28 (87.5%) | 0.361 | |
| Day 1 MADRS score | Mean (SD) | 30.2 (4.48) | 29.9 (4.14) | 29.3 (5.80) | 31.4 (5.19) | 29.9 (4.61) | 0.5111 |
| Median (IQR) | 30 (27–34) | 29.5 (27.25–31.75) | 29 (25.25–31.75) | 31 (28–34) | 29 (27.5–34) | N/A | |
P values are calculated using Fisher’s exact test for the number of prior depressive episodes, failed ECT pre-study, and number taking ADs pre-study entry; and analysis of variance (ANOVA) for age and day 1 MADRS score. The ANOVA was based on regressing the variable (treatment resistance, MADRS and so on) on the dose group.
AD, antidepressant; ECT, electroconvulsive therapy; IQR, interquartile range; N/A, not available.