Assessment of symptom change from improvement curves on the Hamilton depression scale in trials with antidepressants

Abstract

A total of 97 patients, who participated in two studies on the relationship between the clinical effect and plasma levels of imipramine and clomipramine, were examined for improvement curves by use of weekly ratings on the Hamilton Depression Scale (HDS). Although we confirmed that our six-item HDS subscale, in contrast to the total 17-item HDS, was a one-dimensional measure of depression, the Rasch analysis showed that the weekly improvement in subscale scores only applied to the individual patient, i.e. an average improvement curve for a group of depressed patients is an abstraction to which the individual curves cannot be transferred. Our results indicate, however, that when the subscale scores are transformed into three clinical categories of depression: no, mild (minor), moderate/-severe (major) they could be described by a common improvement curve for all patients. This is illustrated by the percentage of patients who, week to week, changed from major to minor or no depression, or from minor to no depression. We found no specific improvement pattern for imipramine or clomipramine which could be used diagnostically. There is reason to assume that patients completing a controlled trial necessarily will follow a monotonic improvement curve, and the improvement pattern of all patients fulfilling the entry criteria should, therefore, always be reported. The present study thus indicates that calculation of average improvement curves is neither clinically nor statistically meaningful, and should be replaced by measures of changes in number of patients in different main severity categories, or by the final rating score. No difference in outcome between imipramine and clomipramine was shown neither on the subscale nor on the 17-item HDS.

The Montgomery Äsberg and the Hamilton ratings of depression: A comparison of measures

“…The HRSD 17 had two factors, with 6-7 items not loading on either factor or loading on both factors. This is consistent with prior reports of the multidimensionality of the HRSD 17 and unidimensionality of the MADRS and the HRSD 6 (Bagby et al, 2004;Bech et al, 1992;Bech et al, 1997;Bech et al, 1984;Bech et al, 1981;Bech et al, 1975;Galinowski and Lehert, 1995;Gibbons et al, 1993;Hamilton, 1967;Maier et al, 1988;Rocca et al, 2002).…”

“…The most commonly used brief HRSD may be that developed by Bech (Bech et al, 1975) -a 6-item scale that includes the following items: depressed mood, guilt, work and activities, retardation, psychic anxiety, and somatic symptoms general. In fact, the HRSD 6 has been found to be more clearly unidimensional (Bagby et al, 2004;Bech et al, 1992;Bech et al, 1997;Bech et al, 1984;Bech et al, 1975), more sensitive to change than the HRSD 17 (de Montigny et al, 1981;O'Sullivan et al, 1997), and equivalent to (Hooper and Bakish, 2000) or more sensitive to detecting drug/placebo or drug/drug differences than the HRSD 17 (Bech et al, 2000;Faries et al, 2000). This briefer version appears to have less psychometric bias as a result of side effects (Moller, 2001).…”

Trajectories of change in depression severity during treatment with antidepressants

“…The rich information on the course of change in depressive symptoms that is commonly discarded in favour of end-point measures may be crucial for understanding how and for whom antidepressants work (Bech et al 1984 ;Stassen et al 2007 ;Szegedi et al 2009). An inspection of individual trajectories of change shows that most variability occurs in the first 3 weeks of the study.…”

Predicting response to treatment and discriminating bipolar and depression symptoms using Hamilton Depression Rating Scale

“…Some argues that depression is a result of multiple causes that makes unfair the definition of depression as a one-dimensional condition. This way, a scale with a good coverage is appropriated when assumes that depression is a result of a set of clinical features, however, the scale must also generate one-dimensional subscales for each clinical feature, in order to evaluate clinical results of pharmacological studies; on the other hand, some researchers criticizes that subscale scores could implies in outperformed results, due to the unspecific items to asses depression symptoms, for example, hypochondriasis and anxiety, that affects directly on depression severity estimates and perceived changes during depressive episode [13][14][15][16][17][18] . Therefore, a short version of HAMD to improve psychometric characteristics and consequently to reduce outperformed results has been developed, to focus in core symptoms and exclude items that are related with medication effects or comorbidities.…”