Rating scales

One of the fundamental issues related to gauging the effectiveness of antidepressants is the choice of a validated rating scale, which is often arbitrary, and that depression symptom scales vary in their psychometric properties, conceptual focus, response burden, and discriminating power. In a study reported as part of the NCDEU sponsored program at Duke University, a community control comparison of four scales in 688 patients was conducted (559 patients with major depression and 129 normal volunteers). The Duke study employed different assessment scales including the MADRAS and the Center for Epidemiologic Studies Depression Scale (CESID), as well as the Carroll Depression Scale (CDS, 52-item scale) and Brief Carroll Depression Scale (BCDS, 12-item scale). The findings from this study using meta-analysis found that the four scales intercorrelated highly significantly, diagnostic specificity was high, and mean depression scores for patients were significantly greater than those of the normal subjects.39 The NCDEU concluded that while validated depression scales effectively separated clinically depressed patients from the community control subjects, they vary in the cognitive burden placed on the patient and the effectiveness measure appears less robust when used in primary care.

Assessing the speed of onset of a new medication is being addressed on several fronts, both from the pharmacological standpoint and in terms of techniques and clinical instruments needed to record the speed of onset of novel antidepressant agents. One enabling technology that is becoming commonplace in clinical studies is the interactive voice response (IVR) technology over the phone line. IVR technology enables remote evaluation of treatment response 24 h a day from any touch phone.39 Such accessibility allows a more frequent monitoring of speed of onset of medication in antidepressant studies. IVR represents a new era of clinical instruments that are currently under investigation to aid the design and outcome measures of clinical trials in depression.34

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