Table 3.
Summary of Select Efficacy Endpoints At Week 12
| Change from Baseline (LS Means (SEM)) |
P-value | Effect Sizea | |||||
|---|---|---|---|---|---|---|---|
| MIN-101 | MIN-101 versus Placebo | MIN-101 versus Placebo | |||||
| Placebo | 32 mg | 64 mg | 32 mg | 64 mg | 32 mg | 64 mg | |
| Primary Objective | |||||||
| Marder’s NSFS (ITT) | –3.5 (0.34) | –4.0 (0.35) | –4.3 (0.34) | .259 | .064 | 0.13 | 0.21 |
| Marder’s NSFS (mITT) | –3.5 (0.35) | –4.0 (0.35) | –4.5 (0.35) | .286 | .044 | 0.13 | 0.26 |
| Key Secondary Objectives | |||||||
| PSP Total Score (ITT) | 3.9 (0.73) | 4.5 (0.75) | 6.1 (0.73) | .542 | .021 | 0.07 | 0.27 |
| PSP Total Score (mITT) | 3.8 (0.75) | 4.4 (0.77) | 6.2 (0.77) | .551 | .017 | 0.07 | 0.29 |
| Secondary and Exploratory | |||||||
| Clinical Global Impression of Severity | –0.3 (0.06) | –0.4 (0.06) | –0.5 (0.06) | .221 | .073 | 0.12 | 0.24 |
| PANSS Constructs | |||||||
| Total Score | –5.5 (0.84) | –7.1 (0.87) | –7.4 (0.85) | .168 | .098 | 0.17 | 0.20 |
| Negative Symptoms Subscore | –3.8 (0.35) | –4.2 (0.35) | –4.7 (0.35) | .392 | .046 | 0.10 | 0.23 |
| Positive Symptoms Subscore | –0.2(0.25) | –0.3 (0.26) | –0.4 (0.25) | .783 | .478 | 0.04 | 0.07 |
| General Psychopathology Subscore | –1.7 (0.45) | –2.8 (0.47) | –2.3 (0.46) | .092 | .380 | 0.22 | 0.12 |
| Marder’s Positive Symptoms Factor Score | –1.0 (2.70) | –1.5 (2.65) | –1.6 (2.86) | .190 | .039 | 0.14 | 0.24 |
| Marder’s Anxiety/Depression Factor Score | –0.5 (0.20) | –0.6 (0.20) | –0.7 (0.20) | .622 | .448 | 0.05 | 0.09 |
| Marder’s Disorganized Thought Factor Score | –1.2 (0.24) | –1.6 (0.25) | –1.4 (0.25) | .279 | .514 | 0.15 | 0.07 |
| Marder’s Uncontrolled Hostility/Excitement Factor Score | 0.2 (0.18) | 0.3 (0.18) | 0.5 (0.18) | .684 | .153 | –0.05 | –0.15 |
| NSFS Emotional Experience Score | –1.3 (0.16) | –1.5 (0.16) | –1.8 (0.16) | .401 | .020 | 0.11 | 0.28 |
| NSFS Emotional Expression Score | –2.3 (0.22) | –2.6 (0.22) | –2.6 (0.22) | .352 | .349 | 0.17 | 0.17 |
| PSP Domains | |||||||
| Self-Care | –0.3 (0.06) | –0.4 (0.06) | –0.3 (0.06) | .261 | .819 | 0.15 | 0.04 |
| Socially Useful Activities | –0.3 (0.05) | –0.3 (0.06) | –0.4 (0.05) | .865 | .047 | 0.02 | 0.18 |
| Personal and Social Relationships | –0.3 (0.06) | –0.4 (0.06) | –0.3 (0.06) | .076 | .501 | 0.15 | 0.00 |
| Disturbing and Aggressive Behaviors | 0.0 (0.05) | 0.0 (0.05) | 0.0 (0.05) | .961 | .186 | 0.00 | –0.07 |
| Clinical Global Impression of Improvementb | 3.3 (0.08) | 3.4 (0.08) | 3.3 (0.08) | .683 | .746 | –0.12 | 0.02 |
| Calgary Depression Scale for Schizophrenia | 0.1 (0.13) | –0.2 (0.13) | –0.1 (0.13) | .093 | .139 | 0.21 | 0.14 |
| Total Verbal Fluencyc | 2.4 (0.64) | 3.9 (0.66) | 1.7 (0.63) | .067 | .327 | 0.21 | –0.10 |
| Responder Analysis d | |||||||
| Number of Patients with 20% Reduction in NSFS at Week 12 | 30/128 (23%) | 32/116 (28%) | 48/122 (39%) | .418 | .006 | 0.05 | 0.17 |
| Number of Patients with 20% Reduction in PANSS Total Score at Week 12 | 12/128 (9%) | 20/116 (17%) | 24/122 (20%) | .061 | .021 | 0.12 | 0.15 |
| Number of Patients with 7-Point Improvement in PSP Total at Week 12 |
37/128 (29%) | 37/116 (32%) | 50/122 (41%) | .589 | .032 | 0.03 | 0.13 |
Note: NSFS, Negative symptoms factor score; PANSS, Positive and negative syndrome scale; PSP, Personal and social performance.
aBased on Cohen’s d.
bObserved data analyzed using MMRM with baseline CGI-S score as covariate.
cBased on sum of 3 trials.
dEffect size is based on Cohen’s W.