Table 2. Efficacy End Point Measures (Intent-to-Treat Population).
| Measure | Lumateperone, 42 mg | Lumateperone, 28 mg | Placebo |
|---|---|---|---|
| PANSS total score, MMRM, No. | 148 | 146 | 141 |
| Change from baseline to day 28, mean (SE) | −15.6 (1.21) | −13.7 (1.22) | −12.4 (1.15) |
| Change from baseline to day 28, LS mean (SE) | −14.5 (1.3) | −12.9 (1.3) | −10.3 (1.3) |
| Difference from placebo, LS mean (95% CI) | −4.2 (−7.8 to −0.6) | −2.6 (−6.2 to 1.1) | NA |
| Effect size | −0.30 | −0.18 | NA |
| Unadjusted P valuea | .02 | .16 | NA |
| Multiplicity-adjusted P value | .04 | .18 | NA |
| CGI-S central score, MMRM, No. | 130 | 123 | 109 |
| Change from baseline to day 28, mean (SE) | −0.9 (0.08) | −0.8 (0.08) | −0.6 (0.08) |
| Change from baseline to day 28, LS mean (SE) | −0.8 (0.07) | −0.8 (0.08) | −0.5 (0.08) |
| Difference from placebo, LS mean (95% CI) | −0.3 (−0.5 to −0.1) | −0.2 (−0.5 to 0.0) | NA |
| Effect size | −0.39 | −0.30 | NA |
| Unadjusted P valuea | .003 | .03 | NA |
| Multiplicity adjusted P value | .04 | NA | NA |
| PANSS positive symptom subscale score, ANCOVA-LOCF, No. | 146 | 145 | 141 |
| Change from baseline to day 28, mean (SE) | −4.8 (0.45) | −4.4 (0.43) | −3.1 (0.43) |
| Change from baseline to day 28, LS mean (SE) | −4.8 (0.42) | −4.4 (0.42) | −3.1 (0.43) |
| Difference from placebo, LS mean (95% CI) | −1.7 (−2.9 to −0.5) | −1.2 (−2.4 to −0.1) | NA |
| Effect size | −0.33 | −0.24 | NA |
| P valuea | .006 | .04 | NA |
| PANSS negative symptom subscale score, ANCOVA-LOCF, No. | 146 | 145 | 141 |
| Change from baseline to day 28, mean (SE) | −1.4 (0.41) | −0.9 (0.39) | −0.7 (0.45) |
| Change from baseline to day 28, LS mean (SE) | −1.4 (0.38) | −1.0 (0.38) | −0.5 (0.39) |
| Difference from placebo, LS mean (95% CI) | −0.9 (−2.0 to 0.2) | −0.5 (−1.6 to 0.6) | NA |
| Effect size | −0.20 | −0.11 | NA |
| P valuea | .09 | .36 | NA |
| PANSS general psychopathology subscale score, ANCOVA-LOCF, No. | 146 | 145 | 141 |
| Change from baseline to day 28, mean(SE) | −7.7 (0.73) | −6.3 (0.77) | −5.2 (0.70) |
| Change from baseline to day 28, LS mean (SE) | −7.6 (0.69) | −6.4 (0.69) | −5.2 (0.70) |
| Difference from placebo, LS mean (95% CI) | −2.4 (−4.3 to −0.5) | −1.2 (−3.1 to 0.7) | NA |
| Effect size | −0.29 | −0.14 | NA |
| P valuea | .01 | .22 | NA |
| PANSS-derived prosocial factor score,ANCOVA-LOCF, No.b | 146 | 145 | 141 |
| Change from baseline to day 28, mean (SE) | −4.9 (0.43) | −4.5 (0.42) | −3.4 (0.42) |
| Change from baseline to day 28, LS mean (SE) | −4.7 (0.39) | −4.5 (0.39) | −3.6 (0.40) |
| Difference from placebo, LS mean (95% CI) | −1.1 (−2.2 to 0) | −1.0 (−2.1 to 0.2) | NA |
| Effect size | −0.24 | −0.20 | NA |
| P valuea | .04 | .09 | NA |
| PSP, ANCOVA, No. | 128 | 121 | 109 |
| Change from baseline to day 28, mean (SE) | 10.9 (1.48) | 10.5 (1.15) | 7.8 (1.38) |
| Change from baseline to day 28, LS mean (SE) | 11.0 (1.13) | 10.5 (1.16) | 7.7 (1.22) |
| Difference from placebo, LS mean (95% CI) | 3.3 (0.1 to 6.6) | 2.9 (−0.4 to 6.2) | NA |
| Effect size | 0.26 | 0.23 | NA |
| P valuea | .05 | .09 | NA |
Abbreviations: ANCOVA, analysis of covariance; CGI-S, Clinical Global Impression–Severity of illness; LOCF, last observation carried forward; LS, least squares; MMRM, mixed-effects model for repeated measures; NA, not applicable; PANSS, Positive and Negative Syndrome Scale; PSP, Personal and Social Performance.
a
P values are nominal and unadjusted for multiplicity unless noted.
b
The PANSS-derived prosocial factor is composed of PANSS items P3 (hallucinatory behavior), P6 (suspiciousness), N2 (emotional withdrawal), N4 (passive-apathetic social withdrawal), N7 (stereotyped thinking), and G16 (active social avoidance).