Results

Thirty-seven patients of the first 50 randomized patients received two MADRS scores at each post-randomization study visit, one by a rater at one of 12 clinical trial sites and by a Sponsor rater. A total of 113 pairs of paired MADRS assessments were conducted. The absolute difference between the site rater and the Sponsor rater is shown in Figure 1. Overall concordance between site and Sponsor raters was 93.4%. The intraclass correlation was 0.9837 and an eta2 = 0.9918 (r = 0.9839, F = 121.91, p < 0.0001). The absolute mean difference in MADRS rating pairs was 1.78 points (95% CI: 1.50-2.06).
Seven of the 113 assessment pairs were discordant, i.e., the MADRS scores differed by 4 points or more between the site rate and the Sponsor rater. Of the 106 concordant pairs, 17 pairs had identical scores, 36 pairs differed by one point, 36 pairs differed by two points, and 17 pairs differed by three points (range 0 to 9). The seven discordant pairs occurred across five clinical trial sites. In six of seven discordant pairs, the site rater assigned a higher MADRS score than the Sponsor rater. In each case of discordant pairs, the Sponsor rater contacted the site rater to provide feedback about the MADRS assessment.