Monday, 18 August 2003
This presentation is part of : Monday Poster Sessions

PA-029 Mirtazapine Orally Disintegrating Tablets in Depressed Nursing Home Patients 85 Years of Age and Older

J. Craig Nelson1, Steven P Roose2, Carl Salzman3, Steven B Hollander4, and John H. Simmons4. (1) Professor of Psychiatry, Leon J. Epstein MD Chair, Geriatric Psychiatry, University of California, San Francisco, San Francisco, CA, USA, (2) Physicians and Surgeons, Columbia University, New York, NY, USA, (3) Psychiatry, Harvard University, Boston, MA, USA, (4) Medical Affairs, Organon Pharmaceuticals, USA Inc., Roseland, NJ, USA

Objective:To evaluate in an open-label naturalistic study, the efficacy of mirtazapine orally disintegrating tablets in depressed nursing home patients with multiple comorbidities >=85 years of age.

Design:Open label 12-week trial.

Materials and Methods:Analysis for patients at least 85 years of age from a larger (n = 124) 12-week open-label trial. Inclusion criteria: physician-diagnosed depression; MMSE scores >=10; residence in a nursing home. Exclusion criteria: unstable medical illness, concomitant antidepressants. The initial dose of mirtazapine was 15 mg/d qhs which could be titrated up to 45 mg/d. At baseline and days 14, 28, 56, and 84 (or early termination), the Investigator/Nurse Coordinator performed a Caregiver Interview with nurses/professionals in daily contact with the patient and recorded CGI (Severity at baseline and Improvement at other visits); 16-item Ham-D (Ham-D-17 minus item 14) and the Cornell Scale for Depression in Dementia. CIRS-G was recorded at baseline. Weight was measured at baseline, day 28, and day 84.

Results:50 patients >= 85 years of age (mean age 89.3 years) at 23 sites. Mean daily dose was 18.5 mg/d. Mean CIRS-G was 11.9 at baseline. CGI and Ham-D-16 response was 55% and 57%, respectively. Mean Ham-D-16 score decreased from 16.9 at baseline to 7.3; mean Cornell Scale score decreased from 15.1 at baseline to 7.1. Mean factor scores for both Anxiety/Somatization and Sleep Disturbance improved over the 12 week trial. Adverse events (>= 10%) included urinary tract infection, fall, accidental injury, vomiting, somnolence, and upper respiratory infection. The rates for falls and accidental injuries resembled that for placebo in other nursing home studies(1). Mean weight change was +0.6kg at day 84. Dropouts due to an AE occurred in 5 subjects, and 1 subject discontinued due to lack of efficacy.

Conclusion:Mirtazapine orally disintegrating tablets were effective and well-tolerated in these depressed nursing home patients with multiple comorbidities who were >= 85 years of age.

1. Street JS et al. Olanzapine treatment of psychotic and behavioral symptoms in patients with Alzheimer’s disease in nursing care facilities. Arch Gen Psychiatry. 2000; 57: 968-976.

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