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

PA-033 Mirtazapine Orally Disintegrating Tablets in Depressed Nursing Home Patients

Steven P Roose1, J. Craig Nelson2, Carl Salzman3, Steven B Hollander4, and James V. Betzel4. (1) Physicians and Surgeons, Columbia University, New York, NY, USA, (2) Professor of Psychiatry, Leon J. Epstein MD Chair, Geriatric Psychiatry, University of California, San Francisco, San Francisco, CA, 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 and tolerability of mirtazapine orally disintegrating tablets in elderly depressed nursing home patients with multiple comorbidities.

Design:Open-label 12-week trial.

Materials and Methods:Inclusion criteria: physician-diagnosed depression; age >= 70 years; MMSE scores >= 10; residence in a nursing home. Exclusion criteria: unstable medical illness, concomitant antidepressants. Mirtazapine 15 mg/d qhs 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 times); 16-item Ham-D (Ham-D-17 minus item 14[genital symptoms]) and the Cornell Scale for Depression in Dementia. Cumulative Illness Rating Scale-Geriatric (CIRS-G) was recorded at baseline.

Results:119 patients (mean age 82.9) at 30 nursing homes. Mean dose was 19.4 mg/d. Mean CIRS-G was 11.4 at baseline. Percentage of CGI responders was 54% after 12 weeks. Mean Ham-D-16 score decreased from 15.7 at baseline to 7.8 at day 84; mean Cornell Scale score decreased from 13.9 at baseline to 7.3 at day 84. Anxiety/somatization and sleep disturbance factor scores also improved. Adverse events (>= 10% of patients) included urinary tract infection, upper respiratory infection, somnolence, fall and accidental injury. The rates of falls and accidental injuries resembled that for placebo in other nursing home studies(1). Mean weight change was +0.7 kg at day 28 and +1.3 kg at day 84. Dropout rate was 34.7%; 14 (11.3%) due to adverse events.

Conclusion:Mirtazapine orally disintegrating tablets were effective and well-tolerated in these nursing home patients with multiple comorbidities.

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; 57:908-976.

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