Table 4.
SDS predictor analysis—data from studies HMAYa, HMAYb, HMCR and HMFT; all randomized patients
| Parameter | Comparison | Total score ≤ 6 at endpoint | Item 1 ≤ 2 at endpoint | Item 2 ≤ 2 at endpoint | Item 3 ≤ 2 at endpoint | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| p‐value | OR (95% CI) | p‐value | OR (95% CI) | p‐value | OR (95% CI) | p‐value | OR (95% CI) | ||||||||||||||
| Study | HMAYa vs HMFT | <0.0001 | 0.48 (0.33, 0.71) | <0.0001 | 0.61 (0.42, 0.88) | <0.0001 | 0.71 (0.51, 0.99) | <0.0001 | 0.81 (0.59, 1.13) | ||||||||||||
| HMAYb vs HMFT | 0.74 (0.52, 1.06) | 0.84 (0.59, 1.20) | 1.04 (0.76, 1.43) | 1.11 (0.81, 1.52) | |||||||||||||||||
| HMCR vs HMFT | 0.33 (0.23, 0.47) | 0.47 (0.34, 0.66) | 0.46 (0.34, 0.61) | 0.38 (0.28, 0.51) | |||||||||||||||||
| Treatment | DLX vs SSRI | 0.069 | 1.22 (0.96, 1.55) | 0.0002 | 1.16 (0.93, 1.46) | 0.0005 | 1.18 (0.96, 1.44) | 0.001 | 1.13 (0.92, 1.38) | ||||||||||||
| PLB vs SSRI | 0.87 (0.61, 1.24) | 0.58 (0.41, 0.82) | 0.66 (0.48, 0.90) | 0.65 (0.48, 0.89) | |||||||||||||||||
| SDS total baseline score | <0.0001 | 0.92 (0.90, 0.94) | <0.0001 | 0.76 (0.72, 0.79) | <0.0001 | 0.84 (0.81, 0.88) | <0.0001 | 0.83 (0.79, 0.86) | |||||||||||||
| HAMD‐17 baseline score | 0.006 | 0.96 (0.94, 0.99) | 0.003 | 0.96 (0.94, 0.99) | 0.001 | 0.96 (0.94, 0.99) | 0.0008 | 0.96 (0.94, 0.99) | |||||||||||||
| Gender | Female vs male | 0.022 | 1.31 (1.04, 1.65) | 0.001 | 1.45 (1.16, 1.82) | 0.0009 | 1.41 (1.15, 1.72) | 0.006 | 1.33 (1.09, 1.62) | ||||||||||||
| Age | 0.385 | 1.00 (0.99, 1.01) | 0.994 | 1.00 (0.99, 1.01) | 0.308 | 1.00 (1.00, 1.01) | 0.306 | 1.00 (1.00, 1.01) | |||||||||||||
| Race | African American vs White | 0.310 | 1.10 (0.74, 1.63) | 0.051 | 0.94 (0.64, 1.37) | 0.661 | 1.15 (0.83, 1.58) | 0.666 | 1.12 (0.81, 1.55) | ||||||||||||
| Other vs White | 0.74 (0.48, 1.14) | 0.59 (0.39, 0.90) | 0.96 (0.69, 1.35) | 0.93 (0.66, 1.30) | |||||||||||||||||
| Number of previous episodes | ≤2 episodes vs missing | 0.887 | 1.07 (0.59, 1.94) | 0.456 | 1.10 (0.64, 1.89) | 0.734 | 0.94 (0.58, 1.53) | 0.474 | 0.81 (0.50, 1.32) | ||||||||||||
| >2 episodes vs missing | 1.00 (0.56, 1.81) | 0.94 (0.55, 1.61) | 0.88 (0.54, 1.42) | 0.75 (0.47, 1.22) | |||||||||||||||||
| Comparison between treatments for SDS total score ≤ 6 at endpoint | Estimate (SE) | OR | p‐value | ||||||||||||||||||
| DLX vs PLB | 0.34 (0.17) | 1.40 | 0.046 | ||||||||||||||||||
| DLX vs SSRI | 0.20 (0.12) | 1.22 | 0.099 | ||||||||||||||||||
| SSRI vs PLB | 0.14 (0.18) | 1.15 | 0.438 | ||||||||||||||||||
| Comparison | SDS item 1 score ≤ 2 at endpoint | SDS item 2 score ≤ 2 At endpoint | SDS item 3 score ≤ 2 at endpoint | ||||||||||||||||||
| Estimate (SE) | OR | p‐value | Estimate (SE) | OR | p‐value | Estimate (SE) | OR | p‐value | |||||||||||||
| DLX vs PLB | 0.69 (0.17) | 2.00 | <0.0001 | 0.58 (0.15) | 1.79 | 0.0001 | 0.55 (0.15) | 1.74 | 0.0001 | ||||||||||||
| DLX vs SSRI | 0.15 (0.12) | 1.16 | 0.204 | 0.16 (0.10) | 1.18 | 0.115 | 0.12 (0.10) | 1.13 | 0.115 | ||||||||||||
| SSRI vs PLB | 0.54 (0.18) | 1.72 | 0.002 | 0.42 (0.16) | 1.52 | 0.008 | 0.43 (0.16) | 1.54 | 0.008 | ||||||||||||
CI, confidence interval; DLX, duloxetine; HAMD‐17, 17‐item Hamilton Depression Rating Scale; OR, odds ratio; PLB, placebo; SDS, Sheehan Disability Scale; SE, standard error; SSRI, selective serotonin reuptake inhibitor.