Table 1.
Baselinea demographic and clinical characteristics
| Characteristic | No prior exposure to BUP/SAM (n = 929) | Prior exposure to BUP/SAM (n = 556) | All patients (N = 1485) |
|---|---|---|---|
| Age, years, mean (SD) | 46.1 (12.4) | 47.3 (12.1) | 46.5 (12.3) |
| Sex, female, n (%) | 616 (66.3) | 348 (62.6) | 964 (64.9) |
| Primary race, n (%) | |||
| White | 681 (73.3) | 399 (71.8) | 1080 (72.7) |
| Black or African American | 224 (24.1) | 138 (24.8) | 362 (24.4) |
| American Indian or Alaska Native | 3 (0.3) | 4 (0.7) | 7 (0.5) |
| Asian | 15 (1.6) | 13 (2.3) | 28 (1.9) |
| Native Hawaiian or other Pacific Islander | 6 (0.6) | 2 (0.4) | 8 (0.5) |
| Region, n (%) | |||
| United States | 735 (79.1) | 469 (84.4) | 1204 (81.1) |
| Non-United States | 194 (20.9) | 87 (15.6) | 281 (18.9) |
| BMI (kg/m2), mean (SD) | 29.6 (5.6) | 29.4 (5.7) | 29.5 (5.6) |
| MADRS total score, mean (SD)b | 19.6 (9.8) | 28.5 (6.4) | 22.9 (9.7) |
| Duration of current MDE (months), mean (SD) | 11.6 (8.6) | 13.2 (5.5) | 12.2 (7.6) |
| Class of drug for depression for current MDE, n (%) | |||
| SSRI | 566 (60.9) | 359 (64.6) | 925 (62.3) |
| SNRI | 256 (27.6) | 139 (25.0) | 395 (26.6) |
| Bupropion | 107 (11.5) | 58 (10.4) | 165 (11.1) |
| No. of inadequate responses for current MDEc, mean (SD) | |||
| 0 | 334 (36.0) | 1 (0.2)d | 335 (22.6)d |
| 1 | 522 (56.2) | 450 (80.9)d | 972 (65.5)d |
| 2+ | 73 (7.9) | 67 (12.1)d | 140 (9.4)d |
BMI body mass index, BUP buprenorphine, MADRS Montgomery–Åsberg Depression Rating Scale, MDE major depressive episode, SAM samidorphan, SD standard deviation, SNRI serotonin–norepinephrine reuptake inhibitor, SSRI selective serotonin reuptake inhibitor
aBaseline was defined as time of BUP/SAM initiation (in FOWARD-2 or lead-in acute study); data shown are for patients who enrolled and had at least one dose of BUP/SAM in the FORWARD-2 study
bBaseline MADRS displayed for patients who also had at least one post-baseline assessment (N = 1453) and were included in efficacy analysis
cFor de novo, this value is the number at visit 2 of FORWARD-2; for patients participating in the prospective lead-in period in the antecedent study (PLI failures), this value represents the number at the end of antecedent study; for patients who roll over from FORWARD-1, this value was not collected at randomization of antecedent study; for others, this value is the number at randomization of antecedent study
dThe 38 patients in the prior exposure group who participated in FORWARD-1 have missing values for this variable, since it was not collected in the prior study