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

Qin Jiang,Saeeduddin Ahmed

doi:10.1186/1744-859x-8-4

Abstract

BackgroundThe 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.ObjectiveThis 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.MethodsChanges from baseline for MADRS, HAM-D17 and CGI-S, and end point CGI-I scores and response (≥50% decrease from baseline HAM-D17 or 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 d.ResultsCorrelations 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-D17 or CGI-S for continuous measures and response.ConclusionAlthough 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.

Highlights

The 17-item Hamilton Depression Rating Scale (HAM-D17) remains the 'gold standard' for measuring treatment outcomes in clinical trials of depressed patients
MADRS and CGI-I were more sensitive to treatment effects, HAM-D17, MADRS, Clinical Global Impressions-Severity scale (CGI-S) and CGI-I scores present a consistent picture of response to venlafaxine treatment
The Hamilton Depression Rating Scale (HAM-D) [1], the Montgomery sberg Depression Rating Scale (MADRS) [2], and the Clinical Global Impressions-Severity scale (CGI-S) and -Improvement scale (CGI-I) [3], are investigator-rated instruments; the CGI-I differs from the other three scales in that it assesses the degree of symptom improvement rather than absolute severity of symptoms or specific pathology [3]

Summary

Introduction

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 sberg Depression Rating Scale (MADRS), Clinical Global Impressions-Severity (CGIS) and -Improvement (CGI-I) scales are widely used. The Hamilton Depression Rating Scale (HAM-D) [1], the Montgomery sberg Depression Rating Scale (MADRS) [2], and the Clinical Global Impressions-Severity scale (CGI-S) and -Improvement scale (CGI-I) [3], are investigator-rated instruments; the CGI-I differs from the other three scales in that it assesses the degree of symptom improvement rather than absolute severity of symptoms or specific pathology [3]. The HAMD and the MADRS scales measure depressive symptoms, whereas the CGI-S and CGI-I assess global outcome. Recent analyses have confirmed the correlation between HAM-D, MADRS, and CGI-S in a systematic literature review and two retrospective chart reviews [4,5,6]

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