An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder

<p>Abstract</p> <p>Background</p> <p>The 17-item Hamilton Depression Rating Scale (HAM-D₁₇) remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients. The Montgomery Ǻsberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) scales are also widely used.</p> <p>Objective</p> <p>This analysis of data from 22 double-blind, placebo-controlled clinical studies of venlafaxine in adult patients with major depressive disorder was aimed at assessing correlations among these 4 scales.</p> <p>Methods</p> <p>Changes from baseline for MADRS, HAM-D₁₇and CGI-S, and end point CGI-I scores and response (≥50% decrease from baseline HAM-D₁₇or MADRS, or CGI-S or CGI-I score ≤2) were analysed. Pearson correlation coefficients were calculated for all pairs of the four scales (HAM-D₁₇/MADRS, HAM-D₁₇/CGI-S, HAM-D₁₇/CGI-I, MADRS/CGI-S, MADRS/CGI-I, CGI-S/CGI-I) at different time points. Effect sizes were calculated using the Cohen <it>d</it>.</p> <p>Results</p> <p>Correlations were significant at all time points (p < 0.0001), increased over the course of treatment, and were similar across treatment groups. Effect sizes ranged from 0.31 to 0.42; MADRS and CGI-I effect sizes were slightly greater compared with HAM-D₁₇or CGI-S for continuous measures and response.</p> <p>Conclusion</p> <p>Although MADRS and CGI-I were more sensitive to treatment effects, HAM-D₁₇, MADRS, CGI-S and CGI-I scores present a consistent picture of response to venlafaxine treatment.</p>

Abstract licence: CC BY-NC-ND

• The clinical global impression scale and the influence of patient or staff perspective on outcome · 2011

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