Mirtazapine orally disintegrating tablets in depressed nursing home residents 85 years of age and older

Introduction Treatment studies of depression in the very oldest patients are infrequent. For these reasons, this study of mirtazapine orally disintegrating tablets was carried out in nursing home residents >= 85 years old with physician-diagnosed depression. The naturalistic conditions of the study allowed us to include patients with cognitive impairment, concomitant medications and comorbid illness. Methods This was a subgroup analysis of nursing home residents >= 85 years old who took part in a larger 12-week open-label trial. Patients were eligible if they had physician-diagnosed depression, and a Mini-Mental State Exam score >= 10. The physician or nurse coordinator obtained data from healthcare professionals in daily contact with the patient to complete the Clinical Global Impression (CGI) scale, a modified 16-item Hamilton Depression Scale (HAM-D), and the Cornell Scale for Depression in Dementia (CSDD). Treatment-emergent adverse events were recorded. Results Of the 50 patients enrolled at 23 sites, 72% completed the 12-week trial. The mean age of the participants was 89.3 years. The mean HAM-D score declined from 16.9 at baseline to 7.3 at endpoint (ITT, LOCF analysis) For the CSDD, the mean score declined from 15.1 to 7.1. The percentage of responders on the CGI-Improvement (CGI-I) scale increased at each assessment reaching 55% at endpoint. Only 10% of the patients discontinued treatment because of adverse events. There was a mean increase in weight of 1.32 lbs (0.6 kg) at day 84. Conclusion Although lacking a placebo control, this naturalistic study suggests that mirtazapine orally disintegrating tablets were effective and well tolerated in this sample of depressed nursing home residents >= 85 years of age. Copyright (c) 2006 John Wiley & Sons, Ltd.