Table 2.
Changes of HAMD17 Total Scores, HAMA Total Scores, HAMA Somatic Anxiety Factor, and HAMD17 Anxiety/Somatization Factor at the End of Week 6 (FAS, LOCF)
| Placebo (n = 49) | Ansofaxine ER tablets | P (a) a | ||||
|---|---|---|---|---|---|---|
| 40 mg (n = 49) | 80 mg (n = 50) | 120 mg (n = 50) | 160 mg (n = 48) | |||
| HAMD17 | ||||||
| LSMEAN | −9.54 | −12.46 | −12.62 | −11.97 | −13.23 | .0447 |
| Average difference from placebo groupb (90% CI) | −2.92 (−5.05, −0.80) |
−3.08 (−5.19, −0.98) |
−2.43 (−4.53, −0.33) |
−3.69 (−5.82, −1.56) |
||
| Average difference from placebo groupb (95% CI) | −2.92 (−6.09, 0.24) |
−3.08 (−6.22, 0.05) |
−2.43 (−5.56, 0.70) |
−3.69 (−6.85, −0.52) |
||
| HAMA total scores | ||||||
| LSMEAN | −6.99 | −9.43 | −10.24 | −8.80 | −10.31 | .0329 |
| Average difference from placebo group (90% CI) | −2.44 (−4.39, −0.49) |
−3.24 (−5.17, −1.31) |
−1.81 (−3.74, 0.12) |
−1.81 (−3.74, 0.12) |
||
| HAMA somatic anxiety factor | ||||||
| LSMEAN | −2.20 | −3.44 | −3.80 | −2.88 | −3.74 | .0295 |
| Average difference from placebo group (90% CI) | −1.23 (−2.18, −0.29) |
−1.59 (−2.54, −0.65) |
−0.68 (−1.62, 0.27) |
−1.53 (−2.49, −0.58) |
||
| HAMD17 anxiety/somatization factor | ||||||
| LSMEAN | −2.50 | −3.35 | −3.56 | −3.22 | −3.68 | .0724 |
| Average difference from placebo group (90% CI) | −0.85 (−1.59, −0.12) |
−1.06 (−1.79, −0.33) |
−0.72 (−1.45, 0.01) |
−1.18 (−1.92, −0.45) |
Abbreviations: CI, confidence interval; ER, extended-release; FAS, full analysis set; HAMD17, 17-item Hamilton Depression Rating Scale; LOCF, last observation carried forward; LSMEAN, least square mean.
a P value (a) by regression of ANCOVA for comparisons across study groups.
b Average differences and 90% CIs were obtained from the regression model (least-square approach) after adjusting other model factors.