| Study 1 | Study 2 | Study 3 | Study 4 | Study 5 | Study 6 | Study 7 | Study 8 | ||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Dose | 60 mg QD | 60 mg QD | 60 mg BID | 60 mg BID | 20 mg BID | 40 mg BID | 20 mg BID | 40 mg BID | 40 mg BID | 60 mg BID | 40 mg BID | 60 mg BID | ||||||||||||
 | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p | Δ | p |
HAMD 17 Total Score | ||||||||||||||||||||||||
MMRM | 4.9 | < .001 | 2.2 | .024 | 3.1 | .009 | 0.9 | .415 | 1.4 | .143 | 1.5 | .116 | 2.4 | .034 | 3.6 | .002 | 2.2 | .001 | 3.3 | < .001 | 1.4 | .045 | 1.6 | .014 |
LOCF | 3.8 | < .001 | 1.7 | .048 | 2.1 | .066 | 0.4 | .681 | 1.2 | .222 | 1.5 | .138 | 2.4 | .022 | 3.1 | .003 | 2.2 | .007 | 3.0 | < .001 | 0.9 | .253 | 1.5 | .054 |
HAMD 17 Maier Subscale | ||||||||||||||||||||||||
MMRM | 2.8 | < .001 | 1.6 | .003 | 2.0 | .005 | 0.7 | .282 | 1.2 | .037 | 1.4 | .012 | 1.1 | .068 | 1.7 | .005 | 1.4 | < .001 | 2.0 | < .001 | 0.9 | .022 | 1.2 | .002 |
LOCF | 2.3 | < .001 | 1.4 | .007 | 1.0 | .030 | 0.6 | .481 | 1.0 | .058 | 1.3 | .012 | 1.5 | .028 | 1.8 | .004 | 1.4 | .001 | 1.9 | < .001 | 0.7 | .090 | 1.0 | .014 |
VAS Overall Pain Severity | ||||||||||||||||||||||||
MMRM | 5.9 | .055 | 4.4 | .135 | NA | NA | 0.3 | .931 | 1.2 | .731 | 1.0 | .771 | 7.4 | .035 | 5.5 | .085 | 6.3 | .050 | 5.6 | .044 | 1.3 | .625 | ||
LOCF | 6.9 | .019 | 5.2 | .037 | NA | NA | 3.5 | .573 | 3.5 | .647 | 3.2 | .710 | 7.1 | .048 | 6.1 | .063 | 5.6 | .086 | 7.8 | .014 | 5.5 | .066 |