An open-label evaluation of the long-term safety of oral venlafaxine in depressed elderly patients.

Abstract

This open-label, multicenter study of depressed men and women > or = 65 years old was conducted at 18 European hospitals to evaluate the safety, efficacy, and clinical acceptability of venlafaxine in elderly depressed patients during 1 year. Patients received venlafaxine orally as 25-mg tablets two or three times daily for up to 12 months, Dosages were titrated upward during the first 15 days and then maintained between 50 and 150 mg/day. Safety was assessed on the basis of study events, vital signs, electrocardiograms tracings, and laboratory determinations. Efficacy was assessed using the Montgomery-Asberg Depression Rating Scale (MADRS), the Clinical Global Impressions (CGI) scale, and the Hospital Anxiety and Depression scale. Patients' subjective ratings of the drug's tolerability and efficacy were collected. Study events were reported by 62% of patients. Few clinically or statistically significant changes occurred in vital signs or electrocardiogram or laboratory findings. No serious study events, including three deaths, were considered unexpected given the nature of the population and the length of treatment. Most patients (81%) believed they had no side effects. Clinical response was achieved in 67% of patients by month 2 (as measured by improvement on the CGI) and by 64% of patients by month 3 (as measured by improvement on the MADRS), suggesting that venlafaxine demonstrates antidepressant efficacy. Eighty-five (73%) patients were still in the study after 6 months and 77 (66%) were still participating at 12 months. Overall, most patients (80%) felt much or very much improved at the end of the study. Venlafaxine was safe, effective, and clinically acceptable treatment for depression in elderly patients.