Table 3.
Efficacy analyses (MMRM-FAS): other outcome measures
| NSI-189 40 mg/day |
NSI-189 80 mg/day |
Placebo | |
|---|---|---|---|
| HAMD-17 | |||
| Stage 1, mean (s.d.) | −8.5 (7.84) | −8.0 (6.93) | −7.4 (7.26) |
| REML estimate (95% CI) | −1.0 (−3.5, 1.5) | −0.9 (−3.4, 1.6) | |
| p value, Cohen’s d | 0.452, = −0.14 | 0.482, −0.13 | |
| Stage 2, mean (s.d.) | −3.4 (6.10) | −2.9 (5.94) | −0.8 (5.55) |
| REML estimate (95% CI) | −1.9 (−5.4, 1.6) | −2.2 (−5.6, 1.2) | |
| p value, Cohen’s d | 0.297, −0.33 | 0.212, −0.38 | |
| Pooled SPCD | |||
| REML estimate (95% CI) | −1.4 (−3.6, 0.7) | −1.5 (−3.6, 0.6) | |
| p value | 0.195 | 0.152 | |
| SDQ | |||
| Stage 1, mean (s.d.) | −37.3 (33.56) | −31.3 (33.96) | −33.3 (27.63) |
| REML estimate (95% CI), p value | −3.0 (−12.4, 6.4) | −0.7 (−10.0, 8.5) | |
| p value, Cohen’s d | 0.532, −0.11 | 0.877, −0.03 | |
| Stage 2, mean (s.d.) | −12.3 (24.73) | 1.6 (23.75) | 1.1 (19.18) |
| REML estimate (95% CI), p value | −13.4 (−26.3, −0.5) | −4.2 (−17.3, 8.8) | |
| p value, Cohen’s d | 0.046, −0.64 | 0.528, −0.20 | |
| Pooled SPCD | |||
| REML estimate (95% CI), p value | −8.2 (−16.2, −0.2) | −2.5 (−10.5, 5.5) | |
| p value | 0.044 | 0.543 | |
| CPFQ | |||
| Stage 1, mean (s.d.) | −8.2 (7.61) | −7.0 (7.24) | −5.7 (6.48) |
| REML estimate (95% CI), p value | −1.7 (−3.8, 0.5) | −1.4 (−3.5, 0.7) | |
| p value, Cohen’s d | 0.133, −0.28 | 0.191, −0.23 | |
| Stage 2, mean (s.d.) | −3.0 (5.66) | −0.5 (4.49) | −0.8 (4.57) |
| REML estimate (95% CI), p value | −2.1 (−4.9, 0.7) | −0.5 (−3.3, 2.4) | |
| p value, Cohen’s d | 0.139, −0.47 | 0.757, −0.10 | |
| Pooled SPCD | |||
| REML estimate (95% CI), p value | −1.9 (−3.7, −0.1) | −0.9 (−2.7, 0.8) | |
| p value | 0.035 | 0.302 | |
| QIDS-SR (ANCOVA) | |||
| Stage 1, mean (s.d.) | −5.2 (5.50) | −4.7 (5.69) | −5.1 (4.90) |
| REML estimate (95% CI), p value | 0.1 (−1.5, 1.8) | 0.0 (−1.7, 1.6) | |
| p value, Cohen’s d | 0.877, 0.03 | 0.960, −0.01 | |
| Stage 2, mean (s.d.) | −2.4 (3.17) | −1.1 (3.65) | 0.2 (4.35) |
| REML estimate (95% CI), p value | −2.5 (−4.8, −0.2) | −1.4 (−3.7, 0.8), 0.210 | |
| p value, Cohen’s d | 0.040, −0.68 | 0.210, −0.39 | |
| Pooled SPCD | |||
| REML estimate (95% CI), p value | −1.2 (−2.6, 0.2), | −0.7 (−2.1, 0.6) | |
| p value | 0.105 | 0.293 | |
| CGI-S | |||
| Stage 1 | |||
| OLS estimate (95% CI) | −0.07 (−0.47, 0.34) | −0.15 (−0.56, 0.26) | |
| p value, Cohen’s d | 0.748, −0.05 | 0.469, −0.07 | |
| Stage 2 | |||
| OLS estimate (95% CI) | −0.45 (−0.97, 0.07) | −0.50 (−1.01, 0.02) | |
| p value, Cohen’s d | 0.092, −0.56 | 0.059, −0.66 | |
| Pooled SPCD | |||
| OLS estimate (95% CI) | −0.26 (−0.59, 0.07) | −0.32 (−0.65, 0.00) | |
| p value | 0.125 | 0.052 | |
| CGI-I | |||
| Stage 1 | |||
| Odds ratio (95% CI) | 0.93 (0.50, 1.74) | 0.71 (0.38, 1.30) | |
| p value, Cohen’s d | 0.830, −0.01 | 0.267, −0.14 | |
| Stage 2 | |||
| Odds ratio (95% CI) | 0.35 (0.12, 1.07) | 0.44 (0.14, 1.36) | |
| p value, Cohen’s d | 0.065, −0.58 | 0.153, −0.46 | |
| Pooled SPCD | |||
| Odds ratio (95%CI) | 0.57 (0.30, 1.08) | 0.55 (0.29, 1.06) | |
| p value | 0.086 | 0.075 | |
MMRM-FAS mixed-effect model repeated measurement-full analysis set, HAMD17 Hamilton Depression Rating Scale-17 Items, SDQ Symptoms of Depression Questionnaire, CPFQ Cognitive and Physical Functioning Scale, QIDS-SR (ANCOVA) Quick Inventory of Depressive Symptomatology Scale-Self Rated (analysis of covariance), CGI-S clinical global impressions-severity, CGI-I clinical global impressions improvement, SPCD = sequential-parallel comparison design;, REML Eestimate = restricted maximal likelihood estimate;, OLS eEstimate = ordinary least- squares estimate;, 95% CI = 95% confidence interval;, s.d. = standard deviation
Bold fonts indicate p values < 0.05