Table 2.
Primary and secondary endpoints at Week 6 of the double‐blind treatment period (Phase B)
| Brexpiprazole | Placebo | ||
|---|---|---|---|
| 1 mg (n = 248) | 2 mg (n = 245) | (n = 243) | |
| MADRS Total Score, MMRM | |||
| Mean (SD) at baseline | 26.7 (6.4) | 26.9 (6.9) | 27.3 (6.2) |
| LSM change at Week 6 (SE) | −8.5 (0.47) | −8.2 (0.47) | −6.7 (0.47) |
| Treatment difference (95% CI) | −1.7 (−3.0, −0.4) | −1.4 (−2.7, −0.1) | |
| P‐value | 0.0089 | 0.0312 | |
| MADRS Response Rate † | |||
| Proportion of responders at Week 6 (LOCF), n (%) | 63 (25.4) | 60 (24.5) | 46 (18.9) |
| Treatment difference (95% CI) | 6.5 (−0.8, 13.8) | 5.6 (−1.7, 12.9) | |
| P‐value | 0.0844 | 0.1364 | |
| MADRS Remission Rate ‡ | |||
| Proportion of patients in remission at Week 6 (LOCF), n (%) | 44 (17.7) | 43 (17.6) | 33 (13.6) |
| Treatment difference (95% CI) | 4.2 (−2.3, 10.6) | 4.0 (−2.5, 10.4) | |
| P‐value | 0.2048 | 0.2265 | |
| CGI‐I Improvement Rate § | |||
| Proportion of responders at Week 6 (LOCF), n (%) | 87 (35.1) | 86 (35.1) | 72 (29.6) |
| Treatment difference (95% CI) | 5.5 (−2.8, 13.7) | 5.5 (−2.8, 13.8) | |
| P value | 0.1969 | 0.1964 | |
| CGI‐S Score, MMRM | |||
| Mean (SD) at baseline | 4.1 (0.6) | 4.2 (0.6) | 4.1 (0.6) |
| LSM change at Week 6 (SE) | −0.7 (0.05) | −0.8 (0.05) | −0.6 (0.05) |
| Treatment difference (95% CI) | −0.1 (−0.3, 0.0) | −0.2 (−0.3, 0.0) | |
| P‐value | 0.0976 | 0.0292 | |
| HAM‐D 17 Total Score, ANCOVA | |||
| Mean (SD) at baseline | 20.5 (4.0) ¶ | 20.8 (3.9) | 21.2 (3.7) |
| LSM change at Week 6 (SE) | −6.3 (0.34) | −5.6 (0.35) | −5.3 (0.35) |
| Treatment difference (95% CI) | −1.0 (−2.0, −0.1) | −0.3 (−1.3, 0.6) | |
| P‐value | 0.0330 | 0.4914 | |
| Mean SDS Score, MMRM | |||
| Mean (SD) at baseline | 5.38 (2.16) †† | 5.62 (2.07) ‡‡ | 5.62 (2.11) §§ |
| LSM change at Week 6 (SE) | −1.13 (0.114) | −1.12 (0.118) | −0.64 (0.115) |
| Treatment difference (95% CI) | −0.49 (−0.81, −0.17) | −0.48 (−0.80, −0.15) | |
| P‐value | 0.0026 | 0.0038 | |
| MADRS‐S Total Score, MMRM | |||
| Mean (SD) at baseline | 10.60 (4.19) | 10.90 (4.59) | 11.01 (4.28) |
| LSM change at Week 6 (SE) | −2.46 (0.199) | −1.87 (0.203) | −1.47 (0.200) |
| Treatment difference (95% CI) | −0.99 (−1.55, −0.44) | −0.41 (−0.97, 0.15) | |
| P‐value | 0.0005 | 0.1543 | |
Abbreviations: ANCOVA, analysis of covariance; CGI‐I, Clinical Global Impression‐Improvement; CGI‐S, Clinical Global Impression‐Severity of Illness; CI, confidence interval; HAM‐D, Hamilton Rating Scale for Depression; LOCF, last observation carried forward; LSM, least squares mean; MADRS, Montgomery‐Åsberg Depression Rating Scale; MADRS‐S, MADRS Self‐report; MMRM, mixed model repeated‐measures; SD, standard deviation; SE, standard error; SDS, Sheehan Disability Scale.
MADRS response rate at Week 6, defined as the proportion of patients with a reduction of ≥50% in MADRS total score from baseline at Week 6.
MADRS remission rate at Week 6, defined as the proportion of patients with a reduction of ≥50% in MADRS total score from baseline at Week 6 and a MADRS total score of ≤10 at Week 6.
CGI‐I improvement rate at Week 6, defined as the proportion of patients with a score of 1 or 2 on the CGI‐I scale at Week 6.
n = 247.
n = 240.
n = 234.
n = 241.