7.2.1.3.6             Efficacy Results

As noted previously, the sponsor focused on the following as key efficacy as key efficacy variables: the 17-item HAMD, the 28-item HAMD, item #1 of the HAMD, the Clinical Global Impression for Severity of Illness (CGI-S), and the Clinical Global Impression for Improvement of Illness (CGI-I).  Appendix 7.2.1.3 presents the data for these key efficacy variables with both the observed case (OC) and the last observation carried forward (LOCF) analyses.  Two-tailed t-test were used to compare changes in each of these variables in the drug- vs. placebo-treated groups at each week of the study.  In addition, chi square “responder analyses” were conducted to test for differences in the proportions of responders in the treatment groups.  For the HAMD analyses, a patient whose total score was reduced by 50 per cent or more between baseline and discontinuation was considered a responder.  For the CGI-I analysis, a patient who was rated as “very much improved” or “much improved” at discontinuation was considered a responder.  The following sections are a brief summary of the findings.

Table 7.2.1.3.6 displays a summary of the statistical comparisons between placebo and both drug treatment groups for the outcome variables.  The reader should not that these are not independent scales.

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