Table 4.
Secondary efficacy end points over the 32 weeks.
| Change from Week 8 to Week 32 | |||||
|---|---|---|---|---|---|
| Characteristics | NAC | Placebo | tb | df | P |
| M (SE)a | M (SE) | ||||
| Symptoms | |||||
| YMRS† | 0.1 (0.4) | 0.4 (0.4) | -0.68 | 129.7 | .500 |
| MADRS†† | 0.6 (1.5) | 1.5 (1.5) | -0.42 | 141.3 | .679 |
| BDRS† | 1.4 (1.4) | 0.7 (1.3) | 0.35 | 139.0 | .726 |
| CGI-BP - Severity† | |||||
| Depression | -0.1 (0.2) | -0.3 (0.2) | 0.5 | 186.5 | .615 |
| Mania | 0.1 (0.1) | -0.1 (0.1) | 0.22 | 160.7 | .826 |
| Overall | 0.1 (0.2) | -0.2 (0.2) | 0.46 | 167.4 | .646 |
| CGI-BP - Improvement | |||||
| Depression | 0.1 (0.3) | 0.2 (0.3) | -0.24 | 105.6 | .814 |
| Mania C | -0.2 (0.2) | 0.0 (0.2) | -1.23 | 67.6 | .222 |
| Overall | 0.1 (0.3) | 0.3 (0.3) | -0.39 | 93.4 | .695 |
| Functioning | |||||
| GAF | -3.2 (1.8) | -4.4 (1.7) | 0.54 | 136.7 | .593 |
| SOFAS | -3.6 (1.8) | -4.5 (1.7) | 0.36 | 165.0 | .719 |
| LIFE-RIFT | 0.5 (0.5) | 1.1 (0.5) | -0.76 | 100.5 | .449 |
| SLICE-LIFE | 0.2 (0.8) | 1.2 (0.8) | -0.89 | 107.4 | .376 |
| QLESQ | -1.7 (1.8) | -2.0 (1.7) | 0.14 | 120.5 | .890 |
YMRS, Young Mania Rating Scale; MADRS, Montgomery-Asberg Depression Rating Scale; BDRS, Bipolar Depression Rating Scale; CGI-BP Clinical Global Impressions - Bipolar Disorder; GAF, Global Assessment of Functioning ; SOFAS, Social and Occupational Assessment Scale; LIFE-RIFT, Range of Impaired Functioning Tool; SLICE-LIFE, Streamed Longitudinal Interval Clinical Evaluation for the Longitudinal Interview Follow-Up Evaluation; Q-LES-Q, Quality of Life Enjoyment and Satisfaction Questionnaire. aLeast squares mean (standard error) derived from MMRM; b Planned comparisons from the MMRM testing the difference in Week 8 to Week 32 change between A and B groups; c Note that the estimate here is derived without investigator in the model, will have to re-run; † Inferential statistics based on logarithmic transformed data (plus constant) because of extreme positive skewness. Untransformed descriptive statistics are reported; †† Inferential statistics based on square root transformation because of positive skewness. Untransformed descriptive statistics are reported.