An analysis of correlations among four outcome scales employed in clinical trials of patients with major depressive disorder.
BACKGROUND
The 17-item Hamilton Depression Rating Scale (HAM-D 17) remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients. The Montgomery Asberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity (CGI-S) and -Improvement (CGI-I) scales are also widely used.


OBJECTIVE
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.


METHODS
Changes from baseline for MADRS, HAM-D 17 and CGI-S, and end point CGI-I scores and response (>or=50% decrease from baseline HAM-D 17 or MADRS, or CGI-S or CGI-I score <or=2) were analysed. Pearson correlation coefficients were calculated for all pairs of the four scales (HAM-D 17/MADRS, HAM-D 17/CGI-S, HAM-D 17/CGI-I, MADRS/CGI-S, MADRS/CGI-I, CGI-S/CGI-I) at different time points. Effect sizes were calculated using the Cohen d.


RESULTS
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-D 17 or CGI-S for continuous measures and response.


CONCLUSIONS
Although MADRS and CGI-I were more sensitive to treatment effects, HAM-D 17, MADRS, CGI-S and CGI-I scores present a consistent picture of response to venlafaxine treatment.
Jiang
Qin
Q
Wyeth Research, Collegeville, Pennsylvania, PA, USA. jiangq2@wyeth.com
Ahmed
Saeeduddin
S